NJG · Flasher, Afterimage, Ophthalmic
Ophthalmic · 21 CFR 886.1300 · Class 2
Overview
| Product Code | NJG |
|---|---|
| Device Name | Flasher, Afterimage, Ophthalmic |
| Regulation | 21 CFR 886.1300 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
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).
Classification Rationale
Class II.
Cleared Devices (0)
No cleared devices on record.
