K163185 is an FDA 510(k) clearance for the OptiLux LED Illuminator, 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 November 21, 2016, 7 days after receiving the submission on November 14, 2016. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K163185 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 2016 |
| Decision Date | November 21, 2016 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | HBI — Illuminator, Fiberoptic, Surgical Field |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |