K013511 is an FDA 510(k) clearance for the XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~). This device is classified as a Light, Surgical, Endoscopic (Class II — Special Controls, product code FSW).
Submitted by Aculux, Inc. (Naples, US). The FDA issued a Cleared decision on February 1, 2002, 102 days after receiving the submission on October 22, 2001.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4580.
| 510(k) Number | K013511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2001 |
| Decision Date | February 01, 2002 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FSW — Light, Surgical, Endoscopic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4580 |