# K211461: Family of Venus RF Systems - Venus Freedom

- Pathway: 510(k) (Traditional)
- Applicant: Venus Concept USA, Inc.
- Decided: Oct 14, 2021 after 156 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: 18 generations back to K943450 (1995). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182094: Family of Venus RF Systems - Heal, Venus Concept USA, Inc. (2019) Summary page 4.

## Indications for use
The Venus Freedom device is intended for the treatment of the following medical conditions; using the Pearl, Diamond and Slim applicators for delivery of non-thermal RF 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/K211461
Methodology: https://510kreport.com/methodology