K213256 is an FDA 510(k) clearance for the ThermoTK, a Massager, Vacuum, Radio Frequency Induced Heat (Class II — Special Controls, product code PBX), submitted by Zimmer Medizinsysteme GmbH (Neu-Elm, DE). The FDA issued a Cleared decision on May 25, 2023, 602 days after receiving the submission on September 30, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.
| 510(k) Number | K213256 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2021 |
| Decision Date | May 25, 2023 |
| Days to Decision | 602 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. |