[Title 21 CFR 886]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 886 - OPHTHALMIC DEVICES]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS81999-04-011999-04-01falseOPHTHALMIC DEVICES886PART 886FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICES
PART 886--OPHTHALMIC DEVICES--Table of Contents
Subpart A--General Provisions
Sec.
886.1 Scope.
886.3 Effective dates of requirement for premarket approval.
886.9 Limitations of exemptions from section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the act).
Subpart B--Diagnostic Devices
886.1040 Ocular esthesiometer.
886.1050 Adaptometer (biophotometer).
886.1070 Anomaloscope.
886.1090 Haidlinger brush.
886.1120 Ophthalmic camera.
886.1140 Ophthalmic chair.
886.1150 Visual acuity chart.
886.1160 Color vision plate illuminator.
886.1170 Color vision tester.
886.1190 Distometer.
886.1200 Optokinetic drum.
886.1220 Corneal electrode.
886.1250 Euthyscope.
886.1270 Exophthalmometer.
886.1290 Fixation device.
886.1300 Afterimage flasher.
886.1320 Fornixscope.
886.1330 Amsler grid.
886.1340 Haploscope.
886.1350 Keratoscope.
[[Page 419]]
886.1360 Visual field laser instrument.
886.1375 Bagolini lens.
886.1380 Diagnostic condensing lens.
886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
886.1390 Flexible diagnostic Fresnel lens.
886.1395 Diagnostic Hruby fundus lens.
886.1400 Maddox lens.
886.1405 Ophthalmic trial lens set.
886.1410 Ophthalmic trial lens clip.
886.1415 Ophthalmic trial lens frame.
886.1420 Ophthalmic lens gauge.
886.1425 Lens measuring instrument.
886.1430 Ophthalmic contact lens radius measuring device.
886.1435 Maxwell spot.
886.1450 Corneal radius measuring device.
886.1460 Stereopsis measuring instrument.
886.1500 Headband mirror.
886.1510 Eye movement monitor.
886.1570 Ophthalmoscope.
886.1605 Perimeter.
886.1630 AC-powered photostimulator.
886.1640 Ophthalmic preamplifier.
886.1650 Ophthalmic bar prism.
886.1655 Ophthalmic Fresnel prism.
886.1660 Gonioscopic prism.
886.1665 Ophthalmic rotary prism.
886.1670 Ophthalmic isotope uptake probe.
886.1680 Ophthalmic projector.
886.1690 Pupillograph.
886.1700 Pupillometer.
886.1750 Skiascopic rack.
886.1760 Ophthalmic refractometer.
886.1770 Manual refractor.
886.1780 Retinoscope.
886.1790 Nearpoint ruler.
886.1800 Schirmer strip.
886.1810 Tangent screen (campimeter).
886.1840 Simulatan (including crossed cylinder).
886.1850 AC-powered slitlamp biomicroscope.
886.1860 Ophthalmic instrument stand.
886.1870 Stereoscope.
886.1880 Fusion and stereoscopic target.
886.1905 Nystagmus tape.
886.1910 Spectacle dissociation test system.
886.1930 Tonometer and accessories.
886.1940 Tonometer sterilizer.
886.1945 Transilluminator.
Subpart C [Reserved]
Subpart D--Prosthetic Devices
886.3100 Ophthalmic tantalum clip.
886.3130 Ophthalmic conformer.
886.3200 Artificial eye.
886.3300 Absorbable implant (scleral buckling method).
886.3320 Eye sphere implant.
886.3340 Extraocular orbital implant.
886.3400 Keratoprosthesis.
886.3600 Intraocular lens.
886.3800 Scleral shell.
886.3920 Eye valve implant.
Subpart E--Surgical Devices
886.4070 Powered corneal burr.
886.4100 Radiofrequency electrosurgical cautery apparatus.
886.4115 Thermal cautery unit.
886.4150 Vitreous aspiration and cutting instrument.
886.4170 Cryophthalmic unit.
886.4230 Ophthalmic knife test drum.
886.4250 Ophthalmic electrolysis unit.
886.4270 Intraocular gas.
886.4275 Intraocular fluid.
886.4280 Intraocular pressure measuring device.
886.4300 Intraocular lens guide.
886.4335 Operating headlamp.
886.4350 Manual ophthalmic surgical instrument.
886.4360 Ocular surgery irrigation device.
886.4370 Keratome.
886.4390 Ophthalmic laser.
886.4392 Nd:YAG laser for posterior capsulotomy.
886.4400 Electronic metal locator.
886.4440 AC-powered magnet.
886.4445 Permanent magnet.
886.4570 Ophthalmic surgical marker.
886.4610 Ocular pressure applicator.
886.4670 Phacofragmentation system.
886.4690 Ophthalmic photocoagulator.
886.4750 Ophthalmic eye shield.
886.4770 Ophthalmic operating spectacles (loupes).
886.4790 Ophthalmic sponge.
886.4855 Ophthalmic instrument table.
Subpart F--Therapeutic Devices
886.5100 Ophthalmic beta radiation source.
886.5120 Low-power binocular loupe.
886.5420 Contact lens inserter/remover.
886.5540 Low-vision magnifier.
886.5600 Ptosis crutch.
886.5800 Ophthalmic bar reader.
886.5810 Ophthalmic prism reader.
886.5820 Closed-circuit television reading system.
886.5840 Magnifying spectacles.
886.5842 Spectacle frame.
886.5844 Prescription spectacle lens.
886.5850 Sunglasses (nonprescription).
886.5870 Low-vision telescope.
886.5900 Electronic vision aid.
886.5910 Image intensification vision aid.
886.5915 Optical vision aid.
886.5916 Rigid gas permeable contact lens.
886.5918 Rigid gas permeable contact lens care products.
886.5925 Soft (hydrophilic) contact lens.
886.5928 Soft (hydrophilic) contact lens care products.
886.5933 [Reserved]
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.
[[Page 420]]
Subpart A--General Provisions
Sec. 886.1 Scope.
(a) This part sets forth the classification of ophthalmic devices
intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is
not a precise description of every device that is, or will be, subject
to the regulation. A manufacturer who submits a premarket notification
submission for a device under part 807 cannot show merely that the
device is accurately described by the section title and identification
provision of a regulation in this part but shall state why the device is
substantially equivalent to other devices, as required by Sec. 807.87.
(c) To avoid duplicative listings, an ophthalmic device that has two
or more types of uses (e.g., used both as a diagnostic device and as a
therapeutic device) is listed in one subpart only.
(d) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21 unless otherwise noted.
Sec. 886.3 Effective dates of requirement for premarket approval.
A device included in this part that is classified into class III
(premarket approval) shall not be commercially distributed after the
date shown in the regulation classifying the device unless the
manufacturer has an approval under section 515 of the act (unless an
exemption has been granted under section 520(g)(2) of the act). An
approval under section 515 of the act consists of FDA's issuance of an
order approving an application for premarket approval (PMA) for the
device or declaring completed a product development protocol (PDP) for
the device.
(a) Before FDA requires that a device commercially distributed
before the enactment date of the amendments, or a device that has been
found substantially equivalent to such a device, has an approval under
section 515 of the act, FDA must promulgate a regulation under section
515(b) of the act requiring such approval, except as provided in
paragraphs (b) and (c) of this section. Such a regulation under section
515(b) of the act shall not be effective during the grace period ending
on the 90th day after its promulgation or on the last day of the 30th
full calendar month after the regulation that classifies the device into
class III is effective, whichever is later. See section 501(f)(2)(B) of
the act. Accordingly, unless an effective date of the requirement for
premarket approval is shown in the regulation for a device classified
into class III in this part, the device may be commercially distributed
without FDA's issuance of an order approving a PMA or declaring
completed a PDP for the device. If FDA promulgates a regulation under
section 515(b) of the act requiring premarket approval for a device,
section 501(f)(1)(A) of the act applies to the device.
(b) Any new, not substantially equivalent, device introduced into
commercial distribution on or after May 28, 1976, including a device
formerly marketed that has been substantially altered, is classified by
statute (section 513(f) of the act) into class III without any grace
period and FDA must have issued an order approving a PMA or declaring
completed a PDP for the device before the device is commercially
distributed unless it is reclassified. If FDA knows that a device being
commercially distributed may be a ``new'' device as defined in this
section because of any new intended use or other reasons, FDA may codify
the statutory classification of the device into class III for such new
use. Accordingly, the regulation for such a class III device states that
as of the enactment date of the amendments, May 28, 1976, the device
must have an approval under section 515 of the act before commercial
distribution.
(c) A device identified in a regulation in this part that is
classified into class III and that is subject to the transitional
provisions of section 520(1) of the act is automatically classified by
statute into class III and must have an approval under section 515 of
the act before being commercially distributed. Accordingly, the
regulation for such a class III transitional device states that as of
the enactment date of the amendments, May 28, 1976, the device must have
an approval under section 515 of the act before commercial distribution.
[[Page 421]]
Sec. 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
(a) FDA's decision to grant an exemption from the requirement of
premarket notification (section 510(k) of the act) for a generic type of
class I device is based upon the existing and reasonably foreseeable
characteristics of commercially distributed devices within that generic
type. Because FDA cannot anticipate every change in intended use or
characteristic that could significantly affect a device's safety or
effectiveness, manufacturers of any commercially distributed class I
device for which FDA has granted an exemption from the requirement of
premarket notification must still submit a premarket notification to FDA
before introducing or delivering for introduction into interstate
commerce for commercial distribution the device when:
(1) The device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent; e.g., the device is intended
for a different medical purpose, or the device is intended for lay use
where the former intended use was by health care professionals only; or
(2) The modified device operates using a different fundamental
scientific technology than that in use in the device before May 28,
1976; e.g., a surgical instrument cuts tissue with a laser beam rather
than with a sharpened metal blade, or an in vitro diagnostic device
detects or identifies infectious agents by using a deoxyribonucleic acid
(DNA) probe or nucleic acid hybridization technology rather than culture
or immunoassay technology.
(b) The exemption from the requirement of premarket notification for
a generic type of class II device applies only to those class II devices
that have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type, or, in the
case of in vitro diagnostic devices, for which a misdiagnosis, as a
result of using the device, would not be associated with high morbidity
or mortality. A class II device for which FDA has granted an exemption
from the requirement of premarket notification must still submit a
premarket notification when:
(1) The device is intended for a use different from the intended use
of a legally marketed device in that generic type of device; e.g., the
device is intended for a different medical purpose, or the device is
intended for lay use where the former intended use was by health care
professionals only; or
(2) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro diagnostic
device detects or identifies infectious agents by using deoxyribonucleic
acid (DNA) probe or nucleic acid hybridization technology rather than
culture or immunoassay technology; or
(3) The device is an in vitro device that is intended:
(i) For use in the diagnosis, monitoring, or screening of neoplastic
diseases with the exception of immunohistochemical devices;
(ii) For use in screening or diagnosis of familial and acquired
genetic disorders, including inborn errors of metabolism;
(iii) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active hepatitis,
tuberculosis, or myocardial infarction or to monitor therapy;
(iv) For assessing the risk of cardiovascular diseases;
(v) For use in diabetes management;
(vi) For identifying or inferring the identity of a microorganism
directly from clinical material;
(vii) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) and IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is intended
for use in matrices other than serum or plasma;
(viii) For noninvasive testing; and
[[Page 422]]
(ix) For near patient testing (point of care).
[53 FR 35603, Sept. 14, 1988, as amended at 63 FR 59229, Nov. 3, 1998]
Subpart B--Diagnostic Devices
Sec. 886.1040 Ocular esthesiometer.
(a) Identification. An ocular esthesiometer is a device, such as a
single-hair brush, intended to touch the cornea to assess corneal
sensitivity.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988;
59 FR 63012, Dec. 7, 1994]
Sec. 886.1050 Adaptometer (biophotometer).
(a) Identification. An adaptometer (biophotometer) is an AC-powered
device that provides a stimulating light source which has various
controlled intensities intended to measure the time required for retinal
adaptation (regeneration of the visual purple) and the minimum light
threshold.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]
Sec. 886.1070 Anomaloscope.
(a) Identification. An anomaloscope is an AC-powered device intended
to test for anomalies of color vision by displaying mixed spectral lines
to be matched by the patient.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]
Sec. 886.1090 Haidlinger brush.
(a) Identification. A Haidlinger brush is an AC-powered device that
provides two conical brushlike images with apexes touching which are
viewed by the patient through a Nicol prism and intended to evaluate
visual function. It may include a component for measuring macular
integrity.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]
Sec. 886.1120 Opthalmic camera.
(a) Identification. An ophthalmic camera is an AC-powered device
intended to take photographs of the eye and the surrounding area.
(b) Classification. Class II.
[55 FR 48441, Nov. 20, 1990]
Sec. 886.1140 Ophthalmic chair.
(a) Identification. An ophthalmic chair is an AC-powered or manual
device with adjustable positioning in which a patient is to sit or
recline during ophthalmological examination or treatment.
(b) Classification. Class I. The AC-powered device and the manual
device are exempt from the premarket notification procedures in subpart
E of part 807 of this chapter. The manual device is also exempt from the
current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]
Sec. 886.1150 Visual acuity chart.
(a) Identification. A visual acuity chart is a device that is a
chart, such as a Snellen chart with block letters or other symbols in
graduated sizes, intended to test visual acuity.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988;
53 FR 40825, Oct. 18, 1988]
[[Page 423]]
Sec. 886.1160 Color vision plate illuminator.
(a) Identification. A color vision plate illuminator is an AC-
powered device that is a lamp intended to properly illuminate color
vision testing plates. It may include a filter.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]
Sec. 886.1170 Color vision tester.
(a) Identification. A color vision tester is a device that consists
of various colored materials, such as colored yarns or color vision
plates (multicolored plates which patients with color vision deficiency
would perceive as being of one color), intended to evaluate color
vision.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988]
Sec. 886.1190 Distometer.
(a) Identification. A distometer is a device intended to measure the
distance between the cornea and a corrective lens during refraction to
help measure the change of the visual image when a lens is in place.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988]
Sec. 886.1200 Optokinetic drum.
(a) Identification. An optokinetic drum is a drum-like device
covered with alternating white and dark stripes or pictures that can be
rotated on its handle. The device is intended to elicit and evaluate
nystagmus (involuntary rapid movement of the eyeball) in patients.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1220 Corneal electrode.
(a) Identification. A corneal electrode is an AC-powered device,
usually part of a special contact lens, intended to be applied directly
to the cornea to provide data showing the changes in electrical
potential in the retina after electroretinography (stimulation by
light).
(b) Classification. Class II.
Sec. 886.1250 Euthyscope.
(a) Identification. A euthyscope is a device that is a modified AC-
powered or battery-powered ophthalmoscope (a perforated mirror device
intended to inspect the interior of the eye) that projects a bright
light encompassing an arc of about 30 degrees onto the fundus of the
eye. The center of the light bundle is blocked by a black disk covering
the fovea (the central depression of the macular retinae where only
cones are present and blood vessels are lacking). The device is intended
for use in the treatment of amblyopia (dimness of vision without
apparent disease of the eye).
(b) Classification. Class I for the battery powered device. The
battery powered device is exempt from premarket notification procedures
in subpart E of part 807 of this chapter. Class II for the AC-powered
device.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]
[[Page 424]]
Sec. 886.1270 Exophthalmometer.
(a) Identification. An exophthalmometer is a device, such as a
ruler, gauge, or caliper, intended to measure the degree of exophthalmos
(abnormal protrusion of the eyeball).
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1290 Fixation device.
(a) Identification. A fixation device is an AC-powered device
intended for use as a fixation target for the patient during
ophthalmological examination. The patient directs his or her gaze so
that the visual image of the object falls on the fovea centralis (the
center of the macular retina of the eye.)
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]
Sec. 886.1300 Afterimage flasher.
(a) Identification. An afterimage flasher is an AC-powered light
that automatically switches on and off to allow performance of an
afterimage test in which the patient indicates the positions of
afterimages after the light is off. The device is intended to determine
harmonious/anomalous retinal correspondence (the condition in which
corresponding points on the retina have the same directional value).
(b) Classification. Class II.
[55 FR 48441, Nov. 20, 1990]
Sec. 886.1320 Fornixscope.
(a) Identification. A fornixscope is a device intended to pull back
and hold open the eyelid to aid examination of the conjunctiva.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1330 Amsler grid.
(a) Identification. An Amsler grid is a device that is a series of
charts with grids of different sizes that are held at 30 centimeters
distance from the patient and intended to rapidly detect central and
paracentral irregularities in the visual field.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1340 Haploscope.
(a) Identification. A haploscope is an AC-powered device that
consists of two movable viewing tubes, each containing a slide carrier,
a low-intensity light source for the illumination of the slides, and a
high-intensity light source for creating afterimages. The device is
intended to measure strabismus (eye muscle imbalance), to assess
binocular vision (use of both eyes to see), and to treat suppression and
amblyopia (dimness of vision without any apparent disease of the eye).
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]
Sec. 886.1350 Keratoscope.
(a) Identification. A keratoscope is an AC-powered or battery-
powered device intended to measure and evaluate the corneal curvature of
the eye. Lines and circles within the keratoscope are used to observe
the corneal reflex. This generic type of device includes the
photokeratoscope which records corneal curvature by taking photographs
of the cornea.
[[Page 425]]
(b) Classification. Class I. The AC-powered device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter only when the device does not include computer software in the
unit. The battery-powered device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. The
battery-powered device is also exempt from the current good
manufacturing practice regulations in part 820 of this chapter, with the
exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]
Sec. 886.1360 Visual field laser instrument.
(a) Identification. A visual field laser instrument is an AC-powered
device intended to provide visible laser radiation that produces an
interference pattern on the retina to evaluate retinal function.
(b) Classification. Class II.
Sec. 886.1375 Bagolini lens.
(a) Identification. A Bagolini lens is a device that consists of a
plane lens containing almost imperceptible striations that do not
obscure visualization of objects. The device is placed in a trial frame
and intended to determine harmonious/anomalous retinal correspondence (a
condition in which corresponding points on the retina have the same
directional values).
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1380 Diagnostic condensing lens.
(a) Identification. A diagnostic condensing lens is a device used in
binocular indirect ophthalmoscopy (a procedure that produces an inverted
or reversed direct magnified image of the eye) intended to focus
reflected light from the fundus of the eye.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.
(a) Identification. A polymethylmethacrylate (PMMA) diagnostic
contact lens is a device that is a curved shell of PMMA intended to be
applied for a short period of time directly on the globe or cornea of
the eye for diagnosis or therapy of intraocular abnormalities.
(b) Classification. Class II.
Sec. 886.1390 Flexible diagnostic Fresnel lens.
(a) Identification. A flexible diagnostic Fresnel lens is a device
that is a very thin lens which has its surface a concentric series of
increasingly refractive zones. The device is intended to be applied to
the back of the spectacle lenses of patients with aphakia (absence of
the lens of the eye).
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1395 Diagnostic Hruby fundus lens.
(a) Identification. A diagnostic Hruby fundus lens is a device that
is a 55 diopter lens intended for use in the examination of the vitreous
body and the
[[Page 426]]
fundus of the eye under slitlamp illumination and magnification.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1400 Maddox lens.
(a) Identification. A Maddox lens is a device that is a series of
red cylinders that change the size, shape, and color of an image. The
device is intended to be handheld or placed in a trial frame to evaluate
eye muscle dysfunction.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1405 Ophthalmic trial lens set.
(a) Identification. An ophthalmic trial lens set is a device that is
a set of lenses of various dioptric powers intended to be handheld or
inserted in a trial frame for vision testing to determine refraction.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996]
Sec. 886.1410 Ophthalmic trial lens clip.
(a) Identification. An ophthalmic trial lens clip is a device
intended to hold prisms, spheres, cylinders, or occluders on a trial
frame or spectacles for vision testing.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1415 Ophthalmic trial lens frame.
(a) Identification. An opthalmic trial lens frame is a mechanical
device intended to hold trial lenses for vision testing.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1420 Ophthalmic lens gauge.
(a) Identification. An ophthalmic lens gauge is a calibrated device
intended to manually measure the curvature of a spectacle lens.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988]
Sec. 886.1425 Lens measuring instrument.
(a) Identification. A lens measuring instrument is an AC-powered
device intended to measure the power of lenses, prisms, and their
centers (e.g., lensometer).
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.1430 Ophthalmic contact lens radius measuring device.
(a) Identification. An ophthalmic contact lens radius measuring
device is an AC-powered device that is a microscope
[[Page 427]]
and dial gauge intended to measure the radius of a contact lens.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.1435 Maxwell spot.
(a) Identification. A Maxwell spot is an AC-powered device that is a
light source with a red and blue filter intended to test macular
function.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.1450 Corneal radius measuring device.
(a) Identification. A corneal radius measuring device is an AC-
powered device intended to measure corneal size by superimposing the
image of the cornea on a scale at the focal length of the lens of a
small, hand held, single tube penscope or eye gauge magnifier.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter only
when the device does not include computer software in the unit or
topographers.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.1460 Stereopsis measuring instrument.
(a) Identification. A stereopsis measuring instrument is a device
intended to measure depth perception by illumination of objects placed
on different planes.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]
Sec. 886.1500 Headband mirror.
(a) Identification. A headband mirror is a device intended to be
strapped to the head of the user to reflect light for use in examination
of the eye.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]
Sec. 886.1510 Eye movement monitor.
(a) Identification. An eye movement monitor is an AC-powered device
with an electrode intended to measure and record ocular movements.
(b) Classification. Class II.
Sec. 886.1570 Ophthalmoscope.
(a) Identification. An ophthalmoscope is an AC-powered or battery-
powered device containing illumination and viewing optics intended to
examine the media (cornea, aqueous, lens, and vitreous) and the retina
of the eye.
(b) Classification. Class II.
Sec. 886.1605 Perimeter.
(a) Identification. A perimeter is an AC-powered or manual device
intended to determine the extent of the peripheral visual field of a
patient. The device projects light on various points of a curved
surface, and the patient indicates whether he or she sees the light.
(b) Classification. Class I. The manual device is exempt from the
premarket notification procedures in part 807, subpart E of this
chapter, and it is also exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198 with respect to the complaint files.
[55 FR 48442, Nov. 20, 1990]
[[Page 428]]
Sec. 886.1630 AC-powered photostimulator.
(a) Identification. An AC-powered photostimulator is an AC-powered
device intended to provide light stimulus which allows measurement of
retinal or visual function by perceptual or electrical methods (e.g.,
stroboscope).
(b) Classification. Class II.
Sec. 886.1640 Ophthalmic preamplifier.
(a) Identification. An ophthalmic preamplifier is an AC-powered or
battery-powered device intended to amplify electrical signals from the
eye in electroretinography (recording retinal action currents from the
surface of the eyeball after stimulation by light), electrooculography
(testing for retinal dysfunction by comparing the standing potential in
the front and the back of the eyeball), and electromyography (recording
electrical currents generated in active muscle).
(b) Classification. Class II.
Sec. 886.1650 Ophthalmic bar prism.
(a) Identification. An ophthalmic bar prism is a device that is a
bar composed of fused prisms of gradually increasing strengths intended
to measure latent and manifest strabismus (eye muscle deviation) or the
power of fusion of a patient's eyes.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]
Sec. 886.1655 Ophthalmic Fresnel prism.
(a) Identification. An ophthalmic Fresnel prism is a device that is
a thin plastic sheet with embossed rulings which provides the optical
effect of a prism. The device is intended to be applied to spectacle
lenses to give a prismatic effect.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]
Sec. 886.1660 Gonioscopic prism.
(a) Identification. A gonioscopic prism is a device that is a prism
intended to be placed on the eye to study the anterior chamber. The
device may have angled mirrors to facilitate visualization of anatomical
features.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988;
59 FR 63013, Dec. 7, 1994]
Sec. 886.1665 Ophthalmic rotary prism.
(a) Identification. An ophthalmic rotary prism is a device with
various prismatic powers intended to be handheld and used to measure
ocular deviation in patients with latent or manifest strabismus (eye
muscle deviation).
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]
Sec. 886.1670 Ophthalmic isotope uptake probe.
(a) Identification. An ophthalmic isotope uptake probe is an AC-
powered device intended to measure, by a probe which is placed in close
proximity to the eye, the uptake of a radioisotope (phosphorus 32) by
tumors to detect
[[Page 429]]
tumor masses on, around, or within the eye.
(b) Classification. Class II.
Sec. 886.1680 Ophthalmic projector.
(a) Identification. An ophthalmic projector is an AC-powered device
intended to project an image on a screen for vision testing.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.1690 Pupillograph.
(a) Identification. A pupillograph is an AC-powered device intended
to measure the pupil of the eye by reflected light and record the
responses of the pupil.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.1700 Pupillometer.
(a) Identification. A pupillometer is an AC-powered or manual device
intended to measure by reflected light the width or diameter of the
pupil of the eye.
(b) Classification. Class I. The AC-powered device and the manual
device are exempt from the premarket notification procedures in subpart
E of part 807 of this chapter. The manual device is also exempt from the
current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.1750 Skiascopic rack.
(a) Identification. A skiascopic rack is a device that is a rack and
a set of attached ophthalmic lenses of various dioptric strengths
intended as an aid in refraction.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996]
Sec. 886.1760 Ophthalmic refractometer.
(a) Identification. An ophthalmic refractometer is an automatic AC-
powered device that consists of a fixation system, a measurement and
recording system, and an alignment system intended to measure the
refractive power of the eye by measuring light reflexes from the retina.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996]
Sec. 886.1770 Manual refractor.
(a) Identification. A manual refractor is a device that is a set of
lenses of varous dioptric powers intended to measure the refractive
error of the eye.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]
Sec. 886.1780 Retinoscope.
(a) Identification. A retinoscope is an AC-powered or battery-
powered device intended to measure the refraction of the eye by
illuminating the retina and noting the direction of movement of the
light on the retinal surface and of the refraction by the eye of the
emergent rays.
(b) Classification. Class I for the battery-powered device. Class II
for the AC-powered device. The battery-powered device is exempt from the
current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180, with respect to general
requirements concerning
[[Page 430]]
records, and Sec. 820.198, with respect to complaint files.
[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990]
Sec. 886.1790 Nearpoint ruler.
(a) Identification. A nearpoint ruler is a device calibrated in
centimeters intended to measure the nearpoint of convergence (the point
to which the visual lines are directed when convergence is at its
maximum).
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988;
53 FR 40825, Oct. 18, 1988]
Sec. 886.1800 Schirmer strip.
(a) Identification. A Schirmer strip is a device made of filter
paper or similar material intended to be inserted under a patient's
lower eyelid to stimulate and evaluate formation of tears.
(b) Classification. Class I. If the device is made of the same
materials that were used in the device before May 28, 1976, the device
is exempt from the premarket notification procedures in part 807,
subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]
Sec. 886.1810 Tangent screen (campimeter).
(a) Identification. A tangent screen (campimeter) is an AC-powered
or battery-powered device that is a large square cloth chart with a
central mark of fixation intended to map on a flat surface the central
30 degrees of a patient's visual field. This generic type of device
includes projection tangent screens, target tangent screens and targets,
felt tangent screens, and stereo campimeters.
(b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter. The battery-powered device is
also exempt from the current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.1840 Simulatan (including crossed cylinder).
(a) Identification. A simulatan (including crossed cylinder) is a
device that is a set of pairs of cylinder lenses that provides various
equal plus and minus refractive strengths. The lenses are arranged so
that the user can exchange the positions of plus and minus cylinder
lenses of equal strengths. The device is intended for subjective
refraction (refraction in which the patient judges whether a given
object is clearly in focus, as the examiner uses different lenses).
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988]
Sec. 886.1850 AC-powered slitlamp biomicroscope.
(a) Identification. An AC-powered slitlamp biomicroscope is an AC-
powered device that is a microscope intended for use in eye examination
that projects into a patient's eye through a control diaphragm a thin,
intense beam of light.
(b) Classification. Class II.
Sec. 886.1860 Ophthalmic instrument stand.
(a) Identification. An ophthalmic instrument stand is an AC-powered
or nonpowered device intended to store ophthalmic instruments in a
readily accessible position.
[[Page 431]]
(b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter. The battery-powered device is
also exempt from the current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.1870 Stereoscope.
(a) Identification. A stereoscope is an AC-powered or battery-
powered device that combines the images of two similar objects to
produce a three-dimensional appearance of solidity and relief. It is
intended to measure the angle of strabismus (eye muscle deviation),
evaluate binocular vision (usage of both eyes to see), and guide a
patient's corrective exercises of eye muscles.
(b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter. The battery-powered device is
also exempt from the current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.1880 Fusion and stereoscopic target.
(a) Identification. A fusion and stereoscopic target is a device
intended for use as a viewing object with a stereoscope (Sec. 886.1870).
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988]
Sec. 886.1905 Nystagmus tape.
(a) Identification. Nystagmus tape is a device that is a long,
narrow strip of fabric or other flexible material on which a series of
objects are printed. The device is intended to be moved across a
patient's field of vision to elicit optokinetic nystagmus (abnormal and
irregular eye movements) and to test for blindness.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988]
Sec. 886.1910 Spectacle dissociation test system.
(a) Identification. A spectacle dissociation test system is an AC-
powered or battery-powered device, such as a Lancaster test system, that
consists of a light source and various filters, usually red or green
filters, intended to subjectively measure imbalance of ocular muscles.
(b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter. The battery-powered device is
also exempt from the current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at
59 FR 63013, Dec. 7, 1994]
Sec. 886.1930 Tonometer and accessories.
(a) Identification. A tonometer and accessories is a manual device
intended
[[Page 432]]
to measure intraocular pressure by applying a known force on the globe
of the eye and measuring the amount of indentation produced (Schiotz
type) or to measure intraocular tension by applanation (applying a small
flat disk to the cornea). Accessories for the device may include a
tonometer calibrator or a tonograph recording system. The device is
intended for use in the diagnosis of glaucoma.
(b) Classification. Class II.
Sec. 886.1940 Tonometer sterilizer.
(a) Identification. A tonometer sterilizer is an AC-powered device
intended to heat sterilize a tonometer (a device used to measure
intraocular pressure).
(b) Classification. Class I.
[55 FR 48443, Nov. 20, 1990]
Sec. 886.1945 Transilluminator.
(a) Identification. A transilluminator is an AC-powered or battery-
powered device that is a light source intended to transmit light through
tissues to aid examination of patients.
(b) Classification. Class I for the battery-powered device. Class II
for the AC-powered device. The battery-powered Class I device is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Subpart C [Reserved]
Subpart D--Prosthetic Devices
Sec. 886.3100 Ophthalmic tantalum clip.
(a) Identification. An ophthalmic tantalum clip is a malleable
metallic device intended to be implanted permanently or temporarily to
bring together the edges of a wound to aid healing or prevent bleeding
from small blood vessels in the eye.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 886.9.
[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]
Sec. 886.3130 Ophthalmic conformer.
(a) Identification. An ophthalmic conformer is a device usually made
of molded plastic intended to be inserted temporarily between the
eyeball and eyelid to maintain space in the orbital cavity and prevent
closure or adhesions during the healing process following surgery. ]
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 886.9.
[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]
Sec. 886.3200 Artificial eye.
(a) Identification. An artificial eye is a device resembling the
anterior portion of the eye, usually made of glass or plastic, intended
to be inserted in a patient's eye socket anterior to an orbital implant,
or the eviscerated eyeball, for cosmetic purposes. The device is not
intended to be implanted.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter if the
device is made from the same materials, has the same chemical
composition, and uses the same manufacturing processes as currently
legally marketed devices.
[61 FR 1124, Jan. 16, 1996]
Sec. 886.3300 Absorbable implant (scleral buckling method).
(a) Identification. An absorbable implant (scleral buckling method)
is a device intended to be implanted on the sclera to aid retinal
reattachment.
(b) Classification. Class II.
Sec. 886.3320 Eye sphere implant.
(a) Identification. An eye sphere implant is a device intended to be
implanted in the eyeball to occupy space following the removal of the
contents of the eyeball with the sclera left intact.
(b) Classification. Class II.
Sec. 886.3340 Extraocular orbital implant.
(a) Identification. An extraocular orbital implant is a
nonabsorbable device intended to be implanted during scleral surgery for
buckling or building up the
[[Page 433]]
floor of the eye, usually in conjunction with retinal reattachment.
Injectable substances are excluded.
(b) Classification. Class II.
Sec. 886.3400 Keratoprosthesis.
(a) Identification. A keratoprosthesis is a device made of plastic
intended to be implanted to replace the central area of an opacified
natural cornea of the eye to maintain or restore sight.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 886.3.
Sec. 886.3600 Intraocular lens.
(a) Identification. An intraocular lens is a device made of
materials such as glass or plastic intended to be implanted to replace
the natural lens of an eye.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See Sec. 886.3.
Sec. 886.3800 Scleral shell.
(a) Identification. A scleral shell is a device made of glass or
plastic that is intended to be inserted for short time periods over the
cornea and proximal-cornea sclera for cosmetic or reconstructive
purposes. An artificial eye is usually painted on the device. The device
is not intended to be implanted.
(b) Classification. Class II (special controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 886.9.
[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]
Sec. 886.3920 Eye valve implant.
(a) Identification. An eye valve implant is a one-way, pressure-
sensitive, valve-like device intended to be implanted to normalize
intraocular pressure. The device may be used in the treatment of
glaucoma.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. No
effective date has been established of the requirement for premarket
approval. See Sec. 886.3.
Subpart E--Surgical Devices
Sec. 886.4070 Powered corneal burr.
(a) Identification. A powered corneal burr is an AC-powered or
battery-powered device that is a motor and drilling tool intended to
remove rust rings from the cornea of the eye.
(b) Classification. Class I.
[55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990]
Sec. 886.4100 Radiofrequency electrosurgical cautery apparatus.
(a) Identification. A radiofrequency electrosurgical cautery
apparatus is an AC-powered or battery-powered device intended for use
during ocular surgery to coagulate tissue or arrest bleeding by a high
frequency electric current.
(b) Classification. Class II.
Sec. 886.4115 Thermal cautery unit.
(a) Identification. A thermal cautery unit is an AC-powered or
battery-powered device intended for use during ocular surgery to
coagulate tissue or arrest bleeding by heat conducted through a wire
tip.
(b) Classification. Class II.
Sec. 886.4150 Vitreous aspiration and cutting instrument.
(a) Identification. A vitreous aspiration and cutting instrument is
an electrically powered device, which may use ultrasound, intended to
remove vitreous matter from the vitreous cavity or remove a crystalline
lens.
(b) Classification. Class II.
Sec. 886.4170 Cryophthalmic unit.
(a) Identification. A cryophthalmic unit is a device that is a probe
with a small tip that becomes extremely cold through the controlled use
of a refrigerant or gas. The device may be AC-powered. The device is
intended to remove cataracts by the formation of an adherent ice ball in
the lens, to freeze the eye and adjunct parts for surgical removal of
scars, and to freeze tumors.
(b) Classification. Class II.
Sec. 886.4230 Ophthalmic knife test drum.
(a) Identification. An ophthalmic knife test drum is a device
intended to
[[Page 434]]
test the keenness of ophthalmic surgical knives to determine whether
resharpening is needed.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988]
Sec. 886.4250 Ophthalmic electrolysis unit.
(a) Identification. An ophthalmic electrolysis unit is an AC-powered
or battery-powered device intended to destroy ocular hair follicles by
applying a galvanic electrical current.
(b) Classification. Class I for the battery-powered device. Class II
for the AC-powered device. The battery-powered Class I device is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]
Sec. 886.4270 Intraocular gas.
(a) Identification. An intraocular gas is a device consisting of a
gaseous fluid intended to be introduced into the eye to place pressure
on a detached retina.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See Sec. 886.3.
Sec. 886.4275 Intraocular fluid.
(a) Identification. An intraocular fluid is a device consisting of a
nongaseous fluid intended to be introduced into the eye to aid
performance of surgery, such as to maintain anterior chamber depth,
preserve tissue integrity, protect tissue from surgical trauma, or
function as a tamponade during retinal reattachment.
(b) Classification. Class III.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See Sec. 886.3.
Sec. 886.4280 Intraocular pressure measuring device.
(a) Identification. An intraocular pressure measuring device is a
manual or AC-powered device intended to measure intraocular pressure.
Also included are any devices found by FDA to be substantially
equivalent to such devices. Accessories for the device may include
calibrators or recorders. The device is intended for use in the
diagnosis of glaucoma.
(b) Classification. Class III.
(c) Date PMA or notice of completion of PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before
this device may be commercially distributed. See Sec. 886.3.
Sec. 886.4300 Intraocular lens guide.
(a) Identification. An intraocular lens guide is a device intended
to be inserted into the eye during surgery to direct the insertion of an
intraocular lens and be removed after insertion is completed.
(b) Classification. Class I.
Sec. 886.4335 Operating headlamp.
(a) Identification. An operating headlamp is an AC-powered or
battery-powered device intended to be worn on the user's head to provide
a light source to aid visualization during surgical, diagnostic, or
therapeutic procedures.
(b) Classification. Class I for the battery-powered device. Class II
for the AC-powered device. The battery powered-device is exempt from the
premarket notification procedures in part 807, subpart E of this
chapter.
[55 FR 48443, Nov. 20, 1990]
Sec. 886.4350 Manual ophthalmic surgical instrument.
(a) Identification. A manual ophthalmic surgical instrument is a
nonpowered, handheld device intended to aid or perform ophthalmic
surgical procedures. This generic type of device includes the manual
corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp,
ophthalmic muscle
[[Page 435]]
clamp, iris retractor clip, orbital compressor, ophthalmic curette,
cystotome, orbital depressor, lachrymal dilator, erisophake, expressor,
ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife,
ophthalmic suturing needle, lachrymal probe, trabeculotomy probe,
cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa),
lachrymal sac rongeur, ophthalmic scissors, enucleating snare,
ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic
spud, trabeculotome or ophthalmic manual trephine.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988;
59 FR 63013, Dec. 7, 1994; 60 FR 15872, Mar. 28, 1995]
Sec. 886.4360 Ocular surgery irrigation device.
(a) Identification. An ocular surgery irrigation device is a device
intended to be suspended over the ocular area during ophthalmic surgery
to deliver continuous, controlled irrigation to the surgical field.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988;
59 FR 63013, Dec. 7, 1994]
Sec. 886.4370 Keratome.
(a) Identification. A keratome is an AC-powered or battery-powered
device intended to shave tissue from sections of the cornea for a
lamellar (partial thickness) transplant.
(b) Classification. Class I.
[55 FR 48443, Nov. 20, 1990]
Sec. 886.4390 Ophthalmic laser.
(a) Identification. An ophthalmic laser is an AC-powered device
intended to coagulate or cut tissue of the eye, orbit, or surrounding
skin by a laser beam.
(b) Classification. Class II.
Sec. 886.4392 Nd:YAG laser for posterior capsulotomy.
(a) Identification. The Nd:YAG laser for posterior capsulotomy
consists of a mode-locked or Q-switched solid state Nd:YAG laser
intended for posterior capsulotomy, which generates short pulse, low
energy, high power, coherent optical radiation. When the laser output is
combined with focusing optics, the high irradiance at the target causes
tissue disruption via optical breakdown. A visible aiming system is
utilized to target the invisible Nd:YAG laser radiation on or in close
proximity to the target tissue.
(b) Classification. Class II.
[53 FR 38947, Oct. 4, 1988]
Sec. 886.4400 Electronic metal locator.
(a) Identification. An electronic metal locator is an AC-powered
device with probes intended to locate metallic foreign bodies in the eye
or eye socket.
(b) Classification. Class II.
Sec. 886.4440 AC-powered magnet.
(a) Identification. An AC-powered magnet is an AC-powered device
that generates a magnetic field intended to find and remove metallic
foreign bodies from eye tissue.
(b) Classification. Class II.
Sec. 886.4445 Permanent magnet.
(a) Identification. A permanent magnet is a nonelectric device that
generates a magnetic field intended to find and remove metallic foreign
bodies from eye tissue.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988]
Sec. 886.4570 Ophthalmic surgical marker.
(a) Identification. An ophthalmic surgical marker is a device
intended to
[[Page 436]]
mark by use of ink, dye, or indentation the location of ocular or
scleral surgical manipulation.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988;
59 FR 63013, Dec. 7, 1994]
Sec. 886.4610 Ocular pressure applicator.
(a) Identification. An ocular pressure applicator is a manual device
that consists of a sphygmomanometer-type squeeze bulb, a dial indicator,
a band, and bellows, intended to apply pressure on the eye in
preparation for ophthalmic surgery.
(b) Classification. Class II.
Sec. 886.4670 Phacofragmentation system.
(a) Identification. A phacofragmentation system is an AC-powered
device with a fragmenting needle intended for use in cataract surgery to
disrupt a cataract with ultrasound and extract the cataract.
(b) Classification. Class II.
Sec. 886.4690 Ophthalmic photocoagulator.
(a) Identification. An ophthalmic photocoagulator is an AC-powered
device intended to use the energy from an extended noncoherent light
source to occlude blood vessels of the retina, choroid, or iris.
(b) Classification. Class II.
Sec. 886.4750 Ophthalmic eye shield.
(a) Identification. An ophthalmic eye shield is a device that
consists of a plastic or aluminum eye covering intended to protect the
eye or retain dressing materials in place.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994]
Sec. 886.4770 Ophthalmic operating spectacles (loupes).
(a) Identification. Ophthalmic operating spectacles (loupes) are
devices that consist of convex lenses or lens systems intended to be
worn by a surgeon to magnify the surgical site during ophthalmic
surgery.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988]
Sec. 886.4790 Ophthalmic sponge.
(a) Identification. An ophthalmic sponge is a device that is an
absorbant sponge, pad, or spear made of folded gauze, cotton, cellulose,
or other material intended to absorb fluids from the operative field in
ophthalmic surgery.
(b) Classification. Class II.
Sec. 886.4855 Ophthalmic instrument table.
(a) Identification. An ophthalmic instrument table is an AC-powered
or manual device on which ophthalmic instruments are intended to be
placed.
(b) Classification. Class I. The AC-powered device and the manual
device are exempt from the premarket notification procedures in subpart
E of part 807 of this chapter. The manual device is also exempt from the
current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180, with respect to general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]
[[Page 437]]
Subpart F--Therapeutic Devices
Sec. 886.5100 Ophthalmic beta radiation source.
(a) Identification. An ophthalmic beta radiation source is a device
intended to apply superficial radiation to benign and malignant ocular
growths.
(b) Classification. Class II.
Sec. 886.5120 Low-power binocular loupe.
(a) Identification. A low-power binocular loupe is a device that
consists of two eyepieces, each with a lens or lens system, intended for
medical purposes to magnify the appearance of objects.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]
Sec. 886.5420 Contact lens inserter/remover.
(a) Identification. A contact lens inserter/remover is a handheld
device intended to insert or remove contact lenses by surface adhesion
or suction.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]
Sec. 886.5540 Low-vision magnifier.
(a) Identification. A low-vision magnifier is a device that consists
of a magnifying lens intended for use by a patient who has impaired
vision. The device may be held in the hand or attached to spectacles.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]
Sec. 886.5600 Ptosis crutch.
(a) Identification. A ptosis crutch is a device intended to be
mounted on the spectacles of a patient who has ptosis (drooping of the
upper eyelid as a result of faulty development or paralysis) to hold the
upper eyelid open.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]
Sec. 886.5800 Ophthalmic bar reader.
(a) Identification. An ophthalmic bar reader is a device that
consists of a magnifying lens intended for use by a patient who has
impaired vision. The device is placed directly onto reading material to
magnify print.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]
Sec. 886.5810 Ophthalmic prism reader.
(a) Identification. An ophthalmic prism reader is a device intended
for use by a patient who is in a supine position to change the angle of
print to aid reading.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E
[[Page 438]]
of this chapter. The device also is exempt from the current good
manufacturing practice regulations in part 820 of this chapter, with the
exception of Sec. 820.180, with respect to general requirements
concerning records, and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]
Sec. 886.5820 Closed-circuit television reading system.
(a) Identification. A closed-circuit television reading system is a
device that consists of a lens, video camera, and video monitor that is
intended for use by a patient who has subnormal vision to magnify
reading material.
(b) Classification. Class I. The AC-powered device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]
Sec. 886.5840 Magnifying spectacles.
(a) Identification. Magnifying spectacles are devices that consist
of spectacle frames with convex lenses intended to be worn by a patient
who has impaired vision to enlarge images.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988;
59 FR 63014, Dec. 7, 1994]
Sec. 886.5842 Spectacle frame.
(a) Identification. A spectacle frame is a device made of metal or
plastic intended to hold prescription spectacle lenses worn by a patient
to correct refractive errors.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994]
Sec. 886.5844 Prescription spectacle lens.
(a) Identification. A prescription spectacle lens is a glass or
plastic device that is a lens intended to be worn by a patient in a
spectacle frame to provide refractive corrections in accordance with a
prescription for the patient. The device may be modified to protect the
eyes from bright sunlight (i.e., prescription sunglasses). Prescription
sunglass lenses may be reflective, tinted, polarizing, or
photosensitized.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988;
59 FR 63014, Dec. 7, 1994]
Sec. 886.5850 Sunglasses (nonprescription).
(a) Identification. Sunglasses (nonprescription) are devices that
consist of spectacle frames or clips with absorbing, reflective, tinted,
polarizing, or photosensitized lenses intended to be worn by a person to
protect the eyes from bright sunlight but not to provide refractive
corrections. This device is usually available over-the-counter.
(b) Classification. Class I.
Sec. 886.5870 Low-vision telescope.
(a) Identification. A low-vision telescope is a device that consists
of an arrangement of lenses or mirrors intended for use by a patient who
has impaired vision to increase the apparent size of objects. This
generic type of device includes handheld or spectacle telescopes.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]
Sec. 886.5900 Electronic vision aid.
(a) Identification. An electronic vision aid is an AC-powered or
battery-powered device that consists of an electronic sensor/transducer
intended for use by a patient who has impaired vision or blindness to
translate visual
[[Page 439]]
images of objects into tactile or auditory signals.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]
Sec. 886.5910 Image intensification vision aid.
(a) Identification. An image intensification vision aid is a
battery-powered device intended for use by a patient who has limited
dark adaptation or impaired vision to amplify ambient light.
(b) Classification. Class I. The device is exempt from the premarket
notification procedures in part 807, subpart E of this chapter. The
device also is exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180, with respect to general requirements concerning records,
and Sec. 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988]
Sec. 886.5915 Optical vision aid.
(a) Identification. An optical vision aid is a device that consists
of a magnifying lens with an accompanying AC-powered or battery-powered
light source intended for use by a patient who has impaired vision to
increase the apparent size of object detail.
(b) Classification. Class I. The AC-powered device and the battery-
powered device are exempt from the premarket notification procedures in
subpart E of part 807 of this chapter. The battery-powered device is
also exempt from the current good manufacturing practice regulations in
part 820 of this chapter, with the exception of Sec. 820.180, with
respect to general requirements concerning records, and Sec. 820.198,
with respect to complaint files.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994]
Sec. 886.5916 Rigid gas permeable contact lens.
(a) Identification. A rigid gas permeable contact lens is a device
intended to be worn directly against the cornea of the eye to correct
vision conditions. The device is made of various materials, such as
cellulose acetate butyrate, polyacrylate-silicone, or silicone
elastomers, whose main polymer molecules generally do not absorb or
attract water.
(b) Classification. (1) Class II if the device is intended for daily
wear only.
(2) Class III if the device is intended for extended wear.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is required before a
device described in paragraph (b)(2) of this section may be commercially
distributed. See Sec. 886.3.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]
Sec. 886.5918 Rigid gas permeable contact lens care products.
(a) Identification. A rigid gas permeable contact lens care product
is a device intended for use in the cleaning, conditioning, rinsing,
lubricating/rewetting, or storing of a rigid gas permeable contact lens.
This includes all solutions and tablets used together with rigid gas
permeable contact lenses.
(b) Classification. Class II (Special Controls) Guidance Document:
``Guidance for Industry Premarket Notification (510(k)) Guidance
Document for Contact Lens Care Products.''
[62 FR 30987, June 6, 1997]
Sec. 886.5925 Soft (hydrophilic) contact lens.
(a) Identification. A soft (hydrophilic) contact lens is a device
intended to be worn directly against the cornea and adjacent limbal and
scleral areas of the eye to correct vision conditions or act as a
therapeutic bandage. The device is made of various polymer materials the
main polymer molecules of which absorb or attract a certain volume
(percentage) of water.
(b) Classification. (1) Class II if the device is intended for daily
wear only.
(2) Class III if the device is intended for extended wear.
(c) Date PMA or notice of completion of a PDP is required. As of May
28, 1976, an approval under section 515 of the act is
[[Page 440]]
required before a device described in paragraph (b)(2) of this section
may be commercially distributed. See Sec. 886.3.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]
Sec. 886.5928 Soft (hydrophilic) contact lens care products.
(a) Identification. A soft (hydrophilic) contact lens care product
is a device intended for use in the cleaning, rinsing, disinfecting,
lubricating/rewetting, or storing of a soft (hydrophilic) contact lens.
This includes all solutions and tablets used together with soft
(hydrophilic) contact lenses and heat disinfecting units intended to
disinfect a soft (hydrophilic) contact lens by means of heat.
(b) Classification. Class II (Special Controls) Guidance Document:
``Guidance for Industry Premarket Notification (510(k)) Guidance
Document for Contact Lens Care Products.''
[62 FR 30988, June 6, 1997]
Sec. 886.5933 [Reserved]