FDA Product Code
FDA Product Code FSR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.4335
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K110528 | INTEGRA LED SURGICAL HEADLIGHT SYSTEM | Integra LifeSciences Corporation | 2011-05-11 | Traditional | PDF ↗ |
| K031549 | SOLID STATE LAMP [LED] HEADLIGHT | Welch Allyn, Inc. | 2003-08-11 | Abbreviated | PDF ↗ |
| K031548 | LED HEADLIGHT | Welch Allyn, Inc. | 2003-08-11 | Abbreviated | PDF ↗ |
| K994362 | HEADLAMP HL2000. | Angiolaz, Inc. | 2000-05-11 | Traditional | PDF ↗ |
Product code FSR · Class II · Ophthalmic. Data: openFDA.