K162512 is an FDA 510(k) clearance for the truSculpt. This device is classified as a Massager, Vacuum, Radio Frequency Induced Heat (Class II - Special Controls, product code PBX).
Submitted by Cutera, Inc. (Brisbane, US). The FDA issued a Cleared decision on December 9, 2016, 92 days after receiving the submission on September 8, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4400. Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite..
| 510(k) Number | K162512 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2016 |
| Decision Date | December 09, 2016 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | PBX — Massager, Vacuum, Radio Frequency Induced Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4400 |
| Definition | Generates Heat In Body Tissues For Minor Relief Of Minor Aches And Pain. Mechanical Massaging To Provide A Temporary Reduction In The Appearance Of Cellulite. |