K222260 is an FDA 510(k) clearance for the Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500. This device is classified as a Massager, Vacuum, Radio Frequency Induced Heat (Class II - Special Controls, product code PBX).
Submitted by Capenergy Medical S.L. (Sant Joan Despi, Barcelona, ES). The FDA issued a Cleared decision on March 28, 2023, 243 days after receiving the submission on July 28, 2022.
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 | K222260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 2022 |
| Decision Date | March 28, 2023 |
| Days to Decision | 243 days |
| Submission Type | Abbreviated |
| 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. |