FCT
6 FDA 510(k) clearances · Product code
88 daysmedian time to decision
182 days90th percentile
6clearances measured
FDA profile
- Official device name
- Headlight, Fiberoptic Focusing
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4335
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1994: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LIGHT COMMANDER (K960767) | Scieran Technologies, Inc. | 1996-08-26 |
| MODIFIED SITE FIBER OPTIC MODULE (K924198) | Chiron Vision Corp. | 1992-11-23 |
| MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE (K883480) | Site Microsurgical Systems, Inc. | 1988-08-24 |
| FIBER OPTIC HEADLIGHT #60-0766766 (K802770) | Aspen Laboratories, Inc. | 1980-12-11 |
| FIBER OPTIC HEADLIGHT #60-0765 (K802769) | Aspen Laboratories, Inc. | 1980-12-11 |
| FIBER OPTIC ADJUSTABLE HEADLIGHT (K780433) | Cameron-Miller, Inc. | 1978-06-13 |
Track FCT automatically
Every clearance here is in the API, with alerts when new ones post.