K102541 is an FDA 510(k) clearance for the CYNOSURE CELLULAZE LASER. This device is classified as a Laser, Cellulite Appearance (Class II - Special Controls, product code OYW).
Submitted by Cynosure, Inc. (Wesford, US). The FDA issued a Cleared decision on January 26, 2012, 510 days after receiving the submission on September 3, 2010.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. For The Removal Of Fat Through Laser Lipolysis..
| 510(k) Number | K102541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2010 |
| Decision Date | January 26, 2012 |
| Days to Decision | 510 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OYW - Laser, Cellulite Appearance |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | For The Removal Of Fat Through Laser Lipolysis. |