The following data is part of a premarket notification filed by Cogent Light Technologies, Inc. with the FDA for Cogenlight Technologies Xls Illuminator System.
| Device ID | K971057 |
| 510k Number | K971057 |
| Device Name: | COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | COGENT LIGHT TECHNOLOGIES, INC. 26145 TECHNOLOGY DR. Santa Clarita, CA 91355 -1137 |
| Contact | Richard B Davies |
| Correspondent | Richard B Davies COGENT LIGHT TECHNOLOGIES, INC. 26145 TECHNOLOGY DR. Santa Clarita, CA 91355 -1137 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-24 |
| Decision Date | 1997-03-28 |
| Summary: | summary |