FSR — Light, Headband, Surgical Class II
FDA product code FSR covers "Light, Headband, Surgical", a Class II medical device regulated under 21 CFR 886.4335. Submissions are reviewed by the Ophthalmic panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FSR
- Device Class
- Class II
- Regulation Number
- 886.4335
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K110528 | integra lifesciences corporation | INTEGRA LED SURGICAL HEADLIGHT SYSTEM | May 11, 2011 |
| K031549 | welch allyn | SOLID STATE LAMP [LED] HEADLIGHT | August 11, 2003 |
| K031548 | welch allyn | LED HEADLIGHT | August 11, 2003 |
| K994362 | angiolaz | HEADLAMP HL2000. | May 11, 2000 |