# K070092: Modification to Velasmooth, Shaper

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Jul 27, 2007 after 198 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: 12 generations back to K943450 (1995). 54 ancestors in all.
128 later devices descend from it; 3 cite it directly.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050397: Velasmooth, Shaper, Syneron Medical, Ltd. (2005) Summary page 1.

## Most influential descendants
- K071872: Velashape (2007), 127 descendants of its own
- K080300: Cutera Multimodal Cellulite Product (Cmmcd) (2008), 101 descendants of its own
- K090221: Reaction System (2009), 54 descendants of its own
- K082622: Alma Lasers Accent B-Shape Massager Handpiece/Module (2009), 45 descendants of its own
- K133837: Viora V-Total (2014), 33 descendants of its own

## Indications for use
The VelaSmooth, Shaper is indicated for temporary reduction of thighs circumferences.

Source page: https://510kreport.com/device/K070092
Methodology: https://510kreport.com/methodology