K031549 is an FDA 510(k) clearance for the SOLID STATE LAMP [LED] HEADLIGHT. This device is classified as a Light, Headband, Surgical (Class II - Special Controls, product code FSR).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on August 11, 2003, 87 days after receiving the submission on May 16, 2003.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4335.
| 510(k) Number | K031549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2003 |
| Decision Date | August 11, 2003 |
| Days to Decision | 87 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | FSR — Light, Headband, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4335 |