K093125 is an FDA 510(k) clearance for the ALPHAXENON LIGHT 180 W AND 300 W, a Light Source, Endoscope, Xenon Arc (Class II — Special Controls, product code GCT), submitted by Gimmi GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on January 27, 2010, 117 days after receiving the submission on October 2, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K093125 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 02, 2009 |
| Decision Date | January 27, 2010 |
| Days to Decision | 117 days |
| Submission Type | Abbreviated |
| 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 |