Headlight, Fiberoptic Focusing
FDA product code FCT · Class II (moderate risk) · 21 CFR 886.4335 · Ophthalmic
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960767 | Light CommanderFCT · Traditional | Scieran Technologies, Inc. | 08/26/1996SE |
| K924198 | Modified Site Fiber Optic ModuleFCT · Traditional | Chiron Vision Corp. | 11/23/1992SE |
| K883480 | Modified Site Fiber Optic Module for Ophthal. UseFCT · Traditional | Site Microsurgical Systems, Inc. | 08/24/1988SE |
| K802770 | Fiber Optic Headlight #60-0766766FCT · Traditional | Aspen Laboratories, Inc. | 12/11/1980SE |
| K802769 | Fiber Optic Headlight #60-0765FCT · Traditional | Aspen Laboratories, Inc. | 12/11/1980SE |
| K780433 | Fiber Optic Adjustable HeadlightFCT · Traditional | Cameron-Miller, Inc. | 06/13/1978SE |