K933405 is an FDA 510(k) clearance for the COGENT LIGHT ILLUMINATOR 10010 XENON LIGHT SOURCE, a Light Source, Endoscope, Xenon Arc (Class II — Special Controls, product code GCT), submitted by Cogent Light Technologies, Inc. (Los Angeles, US). The FDA issued a Cleared decision on February 18, 1994, 221 days after receiving the submission on July 12, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K933405 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 1993 |
| Decision Date | February 18, 1994 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GCT — Light Source, Endoscope, Xenon Arc |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |