# K182094: Family of Venus RF Systems - Heal

- Pathway: 510(k) (Special)
- Applicant: Venus Concept USA, Inc.
- Decided: Feb 1, 2019 after 182 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: 17 generations back to K943450 (1995). 66 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 68 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 4.

## Most influential descendants
- K211461: Family of Venus RF Systems - Venus Freedom (2021), 0 descendants of its own

## Indications for use
The Venus Heal device is intended for the treatment of the following medical conditions; using the Large and Small 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/K182094
Methodology: https://510kreport.com/methodology