K101510 is an FDA 510(k) clearance for the FRACTIONAL SKIN RESURFACING (FSR) APPLICATOR. This device is classified as a Skin Resurfacing Rf Applicator (Class II - Special Controls, product code OUH).
Submitted by Endymed Medical, Ltd. (Binyamina, IL). The FDA issued a Cleared decision on February 17, 2011, 261 days after receiving the submission on June 1, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Skin Resurfacing.
| 510(k) Number | K101510 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2010 |
| Decision Date | February 17, 2011 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OUH - Skin Resurfacing Rf Applicator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Skin Resurfacing |