K231092 is an FDA 510(k) clearance for the T-SHAPE 2. This device is classified as a Massager, Vacuum, Light Induced Heating (Class II - Special Controls, product code NUV).
Submitted by B&M S.R.L. Marketing Nel Benessere (Milano, IT). The FDA issued a Cleared decision on September 22, 2023, 157 days after receiving the submission on April 18, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4810. The Device Is Intended To Temporarily Alter The Appearance Of Cellulite.
| 510(k) Number | K231092 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2023 |
| Decision Date | September 22, 2023 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | NUV - Massager, Vacuum, Light Induced Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | The Device Is Intended To Temporarily Alter The Appearance Of Cellulite |