# K122579: Velashape

- Pathway: 510(k) (Special)
- Applicant: Syneron Medical, Ltd.
- Decided: Sep 13, 2012 after 21 days
- Product code: NUV (Massager, Vacuum, Light Induced Heating)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K943450 (1995). 56 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071872: Velashape, Syneron Medical, Ltd. (2007) Summary page 1.

## Most influential descendants
- K161892: Slimming Treatment Device (2017), 1 descendant of its own
- K261582: Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) (2026), 0 descendants of its own
- K231092: T-Shape 2 (2023), 0 descendants of its own
- K152087: HeatLux Pro II (2016), 0 descendants of its own

## Indications for use
The VelaShape is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite, and for temporary reduction of thighs circumferences.

Source page: https://510kreport.com/device/K122579
Methodology: https://510kreport.com/methodology