K936048 is an FDA 510(k) clearance for the LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND), a Light, Surgical, Fiberoptic (Class II — Special Controls, product code FST), submitted by Cogent Light Technologies, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on March 10, 1994, 80 days after receiving the submission on December 20, 1993. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K936048 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 1993 |
| Decision Date | March 10, 1994 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FST — Light, Surgical, Fiberoptic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |