K213308 is an FDA 510(k) clearance for the Venus BlissMAX. This device is classified as a Massager, Vacuum, Radio Frequency Induced Heat (Class II - Special Controls, product code PBX).
Submitted by Venus Concept USA, Inc. (Weston, US). The FDA issued a Cleared decision on January 12, 2022, 100 days after receiving the submission on October 4, 2021.
This device falls under the Physical Medicine 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 | K213308 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 2021 |
| Decision Date | January 12, 2022 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| 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. |