Light, Headband, Surgical
FDA product code FSR · Class II (moderate risk) · 21 CFR 886.4335 · Ophthalmic
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110528 | Integra LED Surgical Headlight SystemFSR · Traditional | Integra LifeSciences Corporation | 05/11/2011SE |
| K031549 | Solid State Lamp [Led] HeadlightFSR · Abbreviated | Welch Allyn, Inc. | 08/11/2003SE |
| K031548 | LED HeadlightFSR · Abbreviated | Welch Allyn, Inc. | 08/11/2003SE |
| K994362 | Headlamp HL2000.FSR · Traditional | Angiolaz, Inc. | 05/11/2000SE |