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Flasher, Afterimage, Ophthalmic

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 886.1300 Afterimage flasher

§ 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]

Flasher, Afterimage, Ophthalmic

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
886.1300
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 886.1300 Afterimage flasher

§ 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]