K123407 is an FDA 510(k) clearance for the 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 March 29, 2013, 144 days after receiving the submission on November 5, 2012.
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 | K123407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2012 |
| Decision Date | March 29, 2013 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| 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. |