K052979 is an FDA 510(k) clearance for the 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE, a Illuminator, Fiberoptic, Surgical Field (Class II — Special Controls, product code HBI), submitted by Isolux, LLC (Naples, US). The FDA issued a Cleared decision on October 31, 2005, 7 days after receiving the submission on October 24, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K052979 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 24, 2005 |
| Decision Date | October 31, 2005 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | HBI — Illuminator, Fiberoptic, Surgical Field |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |