# K190743: Venus Bliss

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept USA, Inc.
- Decided: Jun 25, 2019 after 95 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: 21 generations back to K943450 (1995). 192 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 197 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143554: Venus Legacy CX, Venus Concept, Ltd. (2015) Summary page 5.
- K160470: SculpSure, Cynosure, Inc. (2016) Summary page 5.

## Most influential descendants
- K213308: Venus BlissMAX (2022), 2 descendants of its own
- K220592: Venus BlissMAX (2022), 1 descendant of its own
- K252845: Venus Nova (FP-2001) (2025), 0 descendants of its own
- K233962: ReBorn (1050nm) (2024), 0 descendants of its own

## Indications for use
The Venus Bliss 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 Bliss 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

Source page: https://510kreport.com/device/K190743
Methodology: https://510kreport.com/methodology