K013880 is an FDA 510(k) clearance for the DAYLITE XENON LIGHT SOURCES, a Light Source, Endoscope, Xenon Arc (Class II — Special Controls, product code GCT), submitted by Designs For Vision, Inc. (Ronkonkoma, US). The FDA issued a Cleared decision on December 7, 2001, 14 days after receiving the submission on November 23, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K013880 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 23, 2001 |
| Decision Date | December 07, 2001 |
| Days to Decision | 14 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 |