FSR
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Light, Headband, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4335
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 2014: 6 · 2020: 13 · 2021: 14
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 |
|---|---|---|
| INTEGRA LED SURGICAL HEADLIGHT SYSTEM (K110528) | Integra LifeSciences Corporation | 2011-05-11 |
| SOLID STATE LAMP [LED] HEADLIGHT (K031549) | Welch Allyn, Inc. | 2003-08-11 |
| LED HEADLIGHT (K031548) | Welch Allyn, Inc. | 2003-08-11 |
| HEADLAMP HL2000. (K994362) | Angiolaz, Inc. | 2000-05-11 |
Track FSR automatically
Every clearance here is in the API, with alerts when new ones post.