The following data is part of a premarket notification filed by Cogent Light Technologies, Inc. with the FDA for Cogent Light Illuminator 10010 Xenon Light Source.
| Device ID | K933405 |
| 510k Number | K933405 |
| Device Name: | COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | COGENT LIGHT TECHNOLOGIES, INC. 650 SOUTH SAN VINCENT BLVD. Los Angeles, CA 90048 -4620 |
| Contact | Robert J Bard |
| Correspondent | Robert J Bard COGENT LIGHT TECHNOLOGIES, INC. 650 SOUTH SAN VINCENT BLVD. Los Angeles, CA 90048 -4620 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-12 |
| Decision Date | 1994-02-18 |