# K213308: Venus BlissMAX

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept USA, Inc.
- Decided: Jan 12, 2022 after 100 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 200 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 203 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190743: Venus Bliss, Venus Concept USA, Inc. (2019) Summary page 4.
- K182440: Body System, A-1 Engineering (2019) Summary page 4.

## Most influential descendants
- K220592: Venus BlissMAX (2022), 1 descendant of its own
- K252845: Venus Nova (FP-2001) (2025), 0 descendants of its own

## Indications for use
The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses: Relief of minor muscle aches and pain, relief of muscle spasm Temporary improvement of local blood circulation Temporary reduction in the appearance of cellulite In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles. The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.

Source page: https://510kreport.com/device/K213308
Methodology: https://510kreport.com/methodology