The following data is part of a premarket notification filed by Cogent Light Technologies, Inc. with the FDA for Lightwear(tm) Syst (lightwear Headlight Clip/headband).
| Device ID | K936048 |
| 510k Number | K936048 |
| Device Name: | LIGHTWEAR(TM) SYST (LIGHTWEAR HEADLIGHT CLIP/HEADBAND) |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | COGENT LIGHT TECHNOLOGIES, INC. 26145 TECHNOLOGY DR. Santa Clarita, CA 91355 -1137 |
| Contact | Enid Rokas |
| Correspondent | Enid Rokas COGENT LIGHT TECHNOLOGIES, INC. 26145 TECHNOLOGY DR. Santa Clarita, CA 91355 -1137 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-20 |
| Decision Date | 1994-03-10 |