Lapas attēli
PDF
ePub

concerning records, and 8820.198, with respect to complaint files. (52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988)

$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 g 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)

$ 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]

$ 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 $ 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 35604, Sept. 14, 1988)

$ 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]

8886.1220 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.

$ 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]

$ 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)

8886.1320 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 $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 35604, Sept. 14, 1988)

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) 8886.1350 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.

(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 regulations in part 820 of this chapter, with the exception of $ 820.180 of this chapter, with respect to general requirements concerning records, and 8820.198 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]

$ 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 $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 35604, Sept. 14, 1988)

$886.1360 Visual field laser instru.

ment. (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.

$ 886.1340 Haploscope.

(a) Identification. A haploscope is an AC-powered device that consists of two

8886.1375 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 ob- concentric series of increasingly rejects. The device is placed in a trial fractive zones. The device is intended frame and intended to determine har- to be applied to the back of the specmonious/anomalous retinal correspond- tacle lenses of patients with aphakia ence (a condition in which cor- (absence of the lens of the eye). responding points on the retina have (b) Classification. Class I. The device the same directional values).

is exempt from the premarket notifica(b) Classification. Class I. The device tion procedures in part 807, subpart E is exempt from the premarket notifica- of this chapter. The device is exempt tion procedures in part 807, subpart E from the current good manufacturing of this chapter. The device is exempt practice regulations in part 820 of this from the current good manufacturing chapter, with the exception of 8820.180, practice regulations in part 820 of this with respect to general requirements chapter, with the exception of $820.180, concerning records, and $ 820.198, with with respect to general requirements respect to complaint files. concerning records, and $820.198, with

(52 FR 33355, Sept. 2, 1987, as amended at 53 respect to complaint files.

FR 35604, Sept. 14, 1988] (52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988)

$ 886.1395 Diagnostic Hruby fundus

lens. 8886.1380 Diagnostic condensing lens. (a) Identification. A diagnostic Hruby

(a) Identification. A diagnostic con- fundus lens is a device that is a 55 diopdensing lens is a device used in bin

ter lens intended for use in the examocular indirect ophthalmoscopy (a pro

ination of the vitreous body and the cedure that produces an inverted or re

fundus of the eye under slitlamp illuversed direct magnified image of the

mination and magnification. eye) intended to focus reflected light

(b) Classification. Class I. The device from the fundus of the eye.

is exempt from the premarket notifica(b) Classification. Class I. The device tion procedures in part 807, subpart E is exempt from the premarket notifica

of this chapter. The device is exempt tion procedures in part 807, subpart E

from the current good manufacturing of this chapter. The device is exempt

practice regulations in part 820 of this from the current good manufacturing

chapter, with the exception of $ 820.180, practice regulations in part 820 of this with respect to general requirements chapter, with the exception of $ 820.180,

concerning records, and $820.198, with with respect to general requirements

respect to complaint files. concerning records, and $820.198, with

(52 FR 33355, Sept. 2, 1987, as amended at 53 respect to complaint files.

FR 35604, Sept. 14, 1988] (52 FR 33355, Sept. 2, 1987, as amended at 53

$ 886.1400 Maddox lens. FR 35604, Sept. 14, 1988]

(a) Identification. A Maddox lens is a $886.1385 Polymethylmethacrylate device that is a series of red cylinders

(PMMA) diagnostic contact lens. that change the size, shape, and color (a) Identification.

A

of an image. The device is intended to polymethylmethacrylate (PMMA) diag

be handheld or placed in a trial frame nostic contact lens is a device that is a

to evaluate eye muscle dysfunction. curved shell of PMMA intended to be

(b) Classification. Class I. The device applied for a short period of time di

is exempt from the premarket notificarectly on the globe or cornea of the eye

tion procedures in part 807, subpart E for diagnosis or therapy of intraocular

of this chapter. The device is exempt abnormalities.

from the current good manufacturing (b) Classification. Class II.

practice regulations in part 820 of this

chapter, with the exception of $ 820.180, 8886.1390 Flexible diagnostic Fresnel with respect to general requirements lens.

concerning records, and $ 820.198, with (a) Identification. A flexible diag

respect to complaint files. nostic Fresnel lens is a device that is a (52 FR 33355, Sept. 2, 1987, as amended at 53 very thin lens which has its surface a FR 35604, Sept. 14, 1988]

(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)

$ 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]

$ 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)

$ 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 $ 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 35604, Sept. 14, 1988)

$ 886.1430 Ophthalmic contact lens ra

dius measuring device. (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.

(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)

8886.1415 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 $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 35604, Sept. 14, 1988)

$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)

8886.1450 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

8886.1420 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 II.

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]

$886.1460 Stereopsis measuring in

strument. (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 $ 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 35605, Sept. 14, 1988]

8886.1605 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 $ 820.180, with respect to general requirements concerning records, and $ 820.198 with respect to the complaint files.

(55 FR 48442, Nov. 20, 1990)

$ 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 $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 35605, Sept. 14, 1988)

8 886.1630 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. 8886.1640 Ophthalmic preamplifier.

(a) Identification. An ophthalmic preamplifier is an AC-powered or batterypowered 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.

$ 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. $ 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.

8 886.1650 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.

194-069 D-01--15

« iepriekšējāTurpināt »