Source: http://ecfr.io/Title-21/pt21.8.886
Timestamp: 2019-07-16 12:13:32
Document Index: 764164870

Matched Legal Cases: ['art 886', 'art 886', 'art 886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', '§886', 'art 886', 'art 807', '§807', 'art 807', '§886', 'art 807', '§886', 'art 820', '§820', '§820', 'art 807', '§886', 'art 820', '§820', '§820', 'art 807', '§886', 'art 807', '§886', 'art 820', '§820', '§820', 'art 807', '§886', 'art 807', '§886', 'art 820', '§820', '§820', 'art 807', '§886', 'art 820', '§820', '§820', 'art 807', '§886', 'art 807', '§886', 'art 820', '§820', '§820', '§886', 'art 807', '§886', 'art 807', '§886', 'art 807', '§886', 'art 807', '§886', '§886', 'art 807', '§886', 'art 807', '§886', 'art 807', '§886', '§886', 'art 807', '§886', 'art 807', '§886', 'art 807', '§886', 'art 820', '§820', '§820', 'art 807', '§886', 'art 807', '§866', '§886']

[21 CFR 886] Title 21 Part 886 : Code of Federal Regulations ';
Title 21 Part 886
Title 21 → Chapter I → Subchapter H → Part 886
§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).
§886.1040 Ocular esthesiometer.
§886.1050 Adaptometer (biophotometer).
§886.1070 Anomaloscope.
§886.1090 Haidinger 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.
§886.1342 Strabismus detection device.
§886.1350 Keratoscope.
§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.
§886.1925 Diurnal pattern recorder system.
§886.1930 Tonometer and accessories.
§886.1940 Tonometer sterilizer.
§886.1945 Transilluminator.
§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 Aqueous shunt.
§886.4070 Powered corneal burr.
§886.4100 Radiofrequency electrosurgical cautery apparatus.
§886.4115 Thermal cautery unit.
§886.4150 Vitreous aspiration and cutting instrument.
§886.4155 Scleral plug.
§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.
§886.4355 Corneal inlay inserter handle.
§886.4360 Ocular surgery irrigation device.
§886.4370 Keratome.
§886.4390 Ophthalmic laser.
§886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.
§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.
§886.5100 Ophthalmic beta radiation source.
§886.5120 Low-power binocular loupe.
§886.5200 Eyelid thermal pulsation system.
§886.5300 Tear electrostimulation device.
§886.5310 Intranasal electrostimulation device for dry eye symptoms.
§886.5420 Contact lens inserter/remover.
§886.5540 Low-vision magnifier.
§886.5600 Ptosis crutch.
§886.5700 Eyelid weight.
§886.5800 Ophthalmic bar reader.
§886.5810 Ophthalmic prism reader.
§886.5820 Closed-circuit television reading system.
§886.5838 Nasolacrimal compression device.
§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.
§886.5905 Oral 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]
Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.
Editorial Note: Nomenclature changes to part 886 appear at 73 FR 35341, June 23, 2008.
(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 §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.
[52 FR 33355, Sept. 2, 1987, as amended at 73 FR 34860, June 19, 2008; 78 FR 18233, Mar. 26, 2013]
(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.
(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.
[65 FR 2320, Jan. 14, 2000]
(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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 59 FR 63012, Dec. 7, 1994; 66 FR 38809, July 25, 2001]
(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.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38809, July 25, 2001]
(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.
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001]
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001; 72 FR 17400, Apr. 9, 2007]
(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
[55 FR 48441, Nov. 20, 1990]
(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, subject to the limitations in §886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.
(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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §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; 66 FR 38810, July 25, 2001]
(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.
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 66 FR 38810, July 25, 2001]
(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.
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001]
(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).
(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 the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9. Class II for the AC-powered device.
(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).
(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.)
(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).
(a) Identification. A fornixscope is a device intended to pull back and hold open the eyelid to aid examination of the conjunctiva.
(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.
(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).
(a) Identification. A strabismus detection device is a prescription device designed to simultaneously illuminate both eyes with polarized light for automated detection of strabismus by analyzing foveal birefringence properties.
(1) Clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. Testing must be conducted in a representative patient population and clinical setting for the indicated use. Demonstration of clinical performance must include assessment of sensitivity and specificity compared to a clearly defined reference standard (e.g., comprehensive ophthalmological examination comprises age-appropriate visual acuity testing, examination of the external ocular adnexae and orbit, anterior segment evaluation, extraocular motility evaluation, assessment of stereopsis, cycloplegic refraction, and dilated fundus examination).
(2) Non-clinical performance testing must demonstrate the device performs as intended under anticipated conditions of use. The following technical characteristics must be evaluated:
(i) Verification of lowest detectable amount of deviation; and
(ii) Validation of the accuracy and precision at the lowest detectable amount of deviation.
(3) Software verification, validation, and hazard analysis must be performed.
(4) Optical radiation safety testing must demonstrate the device is safe per the directions for use.
(5) Performance testing must demonstrate the electromagnetic compatibility of the device.
(6) Performance testing must demonstrate the electrical safety of the device.
(7) Labeling must include the following:
(i) Summaries of non-clinical and clinical performance testing;
(ii) Instructions on how to correctly use and maintain the device;
(iii) Instructions and explanation of all user-interface components; and
(iv) Information related to electromagnetic compatibility and optical radiation classification.
[81 FR 65280, Sept. 22, 2016]
(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.
(b) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180 of this chapter, with respect to general requirements concerning records, and §820.198 of this chapter, with respect to complaint files
[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 65 FR 2320, Jan. 14, 2000]
(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.
(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).
(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.
(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.
(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).
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001]
(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 fundus of the eye under slitlamp illumination and magnification.
(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.
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38811, July 25, 2001]
(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.
(a) Identification. An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision testing.
(a) Identification. An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle lens.
(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).
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, 2001]
(a) Identification. An ophthalmic contact lens radius measuring device is an AC-powered device that is a microscope and dial gauge intended to measure the radius of a contact lens.
(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.
(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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9, only when the device does not include computer software in the unit or topographers.
(a) Identification. A stereopsis measuring instrument is a device intended to measure depth perception by illumination of objects placed on different planes.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38811, July 25, 2001]
(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.
(a) Identification. An eye movement monitor is an AC-powered device with an electrode intended to measure and record ocular movements.
(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.
(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.
[55 FR 48442, Nov. 20, 1990, as amended at 66 FR 38811, July 25, 2001]
(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).
(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).
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, 2001]
(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.
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001]
(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).
(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 tumor masses on, around, or within the eye.
(a) Identification. An ophthalmic projector is an AC-powered device intended to project an image on a screen for vision testing.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001]
(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.
(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 (general controls). The AC-powered device and the manual device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9. The manual device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38812, July 25, 2001]
(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.
(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.
(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. (1) Class II (special controls) for the AC-powered device.
(2) Class I (general controls) for the battery-powered device. The class I battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9. The battery-powered device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180 of this chapter, with respect to general requirements concerning records, and §820.198 of this chapter, with respect to complaint files.
[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 65 FR 2320, Jan. 14, 2000]
(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).
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 53 FR 40825, Oct. 18, 1988; 66 FR 38812, July 25, 2001]
(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 (general controls). 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 subpart E of part 807 of this chapter, subject to the limitations in §886.9.
(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 (general controls). 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, subject to the limitations in §886.9. The battery-powered device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, with respect to general requirements concerning records, and §820.198, with respect to complaint files.
(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).
(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.
(a) Identification. An ophthalmic instrument stand is an AC-powered or nonpowered device intended to store ophthalmic instruments in a readily accessible position.
(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.
[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]
(a) Identification. A fusion and stereoscopic target is a device intended for use as a viewing object with a stereoscope (§886.1870).
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001]
(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.
(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.
[55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]
(a) Identification. A diurnal pattern recorder system is a nonimplantable, prescription device incorporating a telemetric sensor to detect changes in ocular dimension for monitoring diurnal patterns of intraocular pressure (IOP) fluctuations.
(1) Clinical performance data must demonstrate that the device and all of its components perform as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:
(i) Ability of the device to detect diurnal changes.
(ii) Tolerability of the system at the corneoscleral interface in the intended use population.
(2) Nonclinical testing must validate measurements in an appropriate nonclinical testing model to ensure ability to detect changes in intraocular pressure.
(3) Patient-contacting components must be demonstrated to be biocompatible.
(4) Any component that is intended to contact the eye must be demonstrated to be sterile throughout its intended shelf life.
(6) Performance testing must demonstrate the electromagnetic compatibility and electromagnetic interference of the device.
(7) Performance testing must demonstrate electrical safety of the device.
(i) Warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions for the safe use of the device, which includes:
(A) Description of all device components and instructions for assembling the device;
(B) Explanations of all available programs and instructions for their use;
(C) Instructions and explanation of all user-interface components;
(E) Instructions for properly maintaining the device.
(iii) A summary of nonclinical testing information to describe EMC safety considerations.
(iv) A summary of safety information obtained from clinical testing.
(v) Patient labeling to convey information regarding appropriate use of device.
[81 FR 34270, May 31, 2016]
(a) Identification. A tonometer and accessories is a manual device intended 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.
(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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9.
[55 FR 48443, Nov. 20, 1990, as amended at 65 FR 2321, Jan. 14, 2000]
(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. The battery-powered device is also exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9. Class II for the AC-powered device.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]
(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 §886.9.
[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]
(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. ]
(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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9, 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, as amended at 66 FR 38813, July 25, 2001]
(a) Identification. An absorbable implant (scleral buckling method) is a device intended to be implanted on the sclera to aid retinal reattachment.
(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.
(a) Identification. An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.
(a) Identification. A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant.
(b) Classification. Class II. The special controls for this device are FDA's:
(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’”
(2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and
(3) “Guidance on 510(k) Submissions for Keratoprostheses.”
[65 FR 17147, Mar. 31, 2000]
(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 §886.3.
(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.
(a) Identification. An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.
(3) “Aqueous Shunts—510(k) Submissions.”
[65 FR 17147, Mar. 31, 2000, as amended at 66 FR 18542, Apr. 10, 2001]
(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 (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9.
[55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 65 FR 2321, Jan. 14, 2000]
(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.
(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.
(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.
(1) The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §886.9 if the material is a surgical grade stainless steel with or without a gold, silver, or titanium coating. The special controls for the surgical grade stainless steel scleral plug (with or without a gold, silver, or titanium coating) are:
[78 FR 68715, Nov. 15, 2013]
(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.
(a) Identification. An ophthalmic knife test drum is a device intended to test the keenness of ophthalmic surgical knives to determine whether resharpening is needed.
(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 device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §886.9.
(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.
(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.
(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.
(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 §886.3.
(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 (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9.
[52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]
(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.
[55 FR 48443, Nov. 20, 1990, as amended at 66 FR 38813, July 25, 2001]
(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 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.
[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; 66 FR 38813, July 25, 2001]
(a) Identification. The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §886.9.CITA>[84 FR 14870, Apr. 12, 2019]
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001]
(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]
(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.
(a) Identification. The Nd:YAG laser for posterior capsulotomy and peripheral iridotomy consists of a mode-locked or Q-switched solid state Nd:YAG laser intended for disruption of the posterior capsule or the iris via optical breakdown. The Nd:YAG laser 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 (special controls). Design Parameters: Device must emit a laser beam with the following parameters: wavelength = 1064 nanometers; spot size = 50 to 100 micros; pulse width = 3 to 30 nanoseconds; output energy per pulse = 0.5 to 15 millijoules (mJ); repetition rate = 1 to 10 pulses; and total energy = 20 to 120 mJ.
[65 FR 6894, Feb. 11, 2000]
(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.
(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.
(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.
(a) Identification. An ophthalmic surgical marker is a device intended to mark by use of ink, dye, or indentation the location of ocular or scleral surgical manipulation.
(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.
(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.
(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.
(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 (general controls). When made only of plastic or aluminum, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9. When made only of plastic or aluminum, the devices are exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180 of this chapter, with respect to general requirements concerning records, and §820.198 of this chapter, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 65 FR 2321, Jan. 14, 2000]
(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.
(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.
(a) Identification. An ophthalmic instrument table is an AC-powered or manual device on which ophthalmic instruments are intended to be placed.
(a) Identification. An ophthalmic beta radiation source is a device intended to apply superficial radiation to benign and malignant ocular growths.
(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.
(a) Identification. An eyelid thermal pulsation system is an electrically-powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.
(2) Design, description, and performance data should validate safeguards related to the temperature and pressure aspects of the device, including during fault conditions;
(3) Performance data should demonstrate the sterility of patient-contacting components and the shelf-life of these components;
(4) The device should be demonstrated to be biocompatible; and
(5) Performance data should demonstrate that any technological changes do not adversely effect safety and effectiveness.
[76 FR 51878, Aug. 19, 2011]
(a) Identification. A tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production.
(1) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(2) Patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(5) Physician and patient labeling must include:
(i) Summaries of electrical stimulation parameters;
(iii) Instructions and explanations of all user-interface components;
(iv) Information related to electromagnetic compatibility classification; and
(v) Instructions on how to clean the device.
[82 FR 60116, Dec. 19, 2017]
(a) Identification. An intranasal electrostimulation device for dry eye symptoms is a prescription non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms.
(1) Clinical performance testing must evaluate improvement of dry eye symptoms under anticipated conditions of use.
(2) Non-clinical performance testing must assess the following electrical output specifications: waveforms, output modes, maximum output voltage, maximum output current, pulse duration, frequency, net charge per pulse, maximum phase charge at 500 ohms, maximum current density, maximum average current, and maximum average power density.
(3) Patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance testing must demonstrate the electrical, thermal, and mechanical safety along with electromagnetic compatibility (EMC) of the device in the intended use environment.
(6) Training for the proper use of the device must be provided.
(7) Physician and patient labeling must include:
(iv) Information related to electromagnetic compatibility classification;
(v) Instructions on how to clean the device; and
(vi) Summaries of clinical performance testing demonstrating safety and effectiveness.
[83 FR 52975, Oct. 19, 2018]
(a) Identification. A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.
(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.
(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.
(a) Identification. An eyelid weight is a prescription device made of gold, tantalum, platinum, iridium, or surgical grade stainless steel that is rectangular in shape and contoured to the shape of the eye. The device is intended for the gravity assisted treatment of lagophthalmos (incomplete eyelid closure).
(1) The external eyelid weight is adhered to the outer skin of the upper eyelid.
(2) The implantable eyelid weight is implanted into the upper eyelid.
(b) Classification. (1) Class II (special controls) for the external eyelid weight. The external eyelid weight is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §886.9. The special controls for the external eyelid weight are:
(i) Testing demonstrating the biocompatibility of the device; and
(ii) Labeling must include the following information:
(A) Specific instructions regarding the proper placement, sizing, and removal of the device; and
(B) A warning stating that the patient should be instructed to remove the device prior to entering a magnetic resonance environment.
(2) Class II (special controls) for the implantable eyelid weight. The special controls for the implantable eyelid weight are:
(i) Testing demonstrating the biocompatibility of the device;
(ii) Testing demonstrating the sterility and shelf life of the device;
(iii) Nonclinical testing evaluating the compatibility of the device in a magnetic resonance environment.
(iv) Patient labeling to convey information regarding the safety and compatibility of the device in a magnetic resonance environment, the conditions under which a patient with the device can be safely scanned, and a mechanism for a healthcare provider to obtain detailed information about magnetic resonance safety and compatibility if needed.
[79 FR 22015, Apr. 21, 2014]
(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.
(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.
(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.
(a) Identification. A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.
[81 FR 37500, June 10, 2016]
(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 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §866.9.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]
(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.
(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.
(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.
(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 images of objects into tactile or auditory signals.
(a) Identification. An oral electronic vision aid is a battery-powered prescription device that contains an electrode stimulation array to generate electrotactile stimulation patterns that are derived from digital object images captured by a camera. It is intended to aid profoundly blind patients in orientation, mobility, and object recognition as an adjunctive device to other assistive methods such as a white cane or a guide dog.
(1) Clinical performance testing must demonstrate an acceptable adverse event profile, including adverse events involving the mouth, tongue, and gums and demonstrate the effect of the stimulation to provide clinically meaningful outcomes. The clinical performance testing must also investigate the anticipated conditions of use, including potential use error, intended environment of use, and duration of use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including simulated moisture ingress, device durability, and battery reliability.
(4) Analysis/testing must validate electromagnetic compatibility.
(5) Analysis/testing must validate electrical safety.
(6) Analysis/testing must assess and validate wireless coexistence concerns.
(7) Any elements of the device that contact the patient must be demonstrated to be biocompatible.
(8) Training must include elements to ensure that the healthcare provider and user can identify the safe environments for device use, use all safety features of the device, and operate the device in the intended environment of use.
(9) Labeling for the trainer and user must include a summary of the clinical testing including adverse events encountered under use conditions, summary of study outcomes and endpoints, and information pertinent to use of the device including the conditions under which the device was studied (e.g., level of supervision or assistance, and environment of use).
[80 FR 57092, Sept. 22, 2015]
(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.
(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.
[55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001]
(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 §886.3.
[52 FR 33355, Sept. 2, 1987, as amended at 59 FR 10284, Mar. 4, 1994]
(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]
(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.
(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.
[62 FR 30988, June 6, 1997]