# K161199: EndyMed Contour Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Endymed Medical, Ltd.
- Decided: Aug 1, 2016 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: 20 generations back to K943450 (1995). 313 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 316 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.
- K150035: V10 system, Viora, Ltd. (2015) Summary page 5.

## Most influential descendants
- K242996: EndyMed PRO MAX (2025), 1 descendant of its own
- K251836: Dermatrix Duo (2026), 0 descendants of its own

## Indications for use
The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage: • 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/K161199
Methodology: https://510kreport.com/methodology