# K050397: Velasmooth, Shaper

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Jun 9, 2005 after 113 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: 11 generations back to K943450 (1995). 53 ancestors in all.
150 later devices descend from it; 8 cite it directly.
0 of 204 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990445: LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/Vibrator, Lpg USA, Inc. (2000) Summary page 1.
- K013197: WS-501 Heat Lamp, Lhasa Medical, Inc. (2002) Summary page 1.
- K003538: TDP CQ-27 Heat Lamp, Lhasa Medical, Inc. (2001) Summary page 1.
- K031988: Aurora DS, Syneron Medical, Ltd. (2003) Summary page 1.
- K030142: Thermacool TC System, Thermage, Inc. (2003)

## Most influential descendants
- K070092: Modification to Velasmooth, Shaper (2007), 128 descendants of its own
- K071872: Velashape (2007), 127 descendants of its own
- K080300: Cutera Multimodal Cellulite Product (Cmmcd) (2008), 101 descendants of its own
- K053611: Smoothshapes (2006), 95 descendants of its own
- K090221: Reaction System (2009), 54 descendants of its own

## Indications for use
Vela smooth, Shaper 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.

Source page: https://510kreport.com/device/K050397
Methodology: https://510kreport.com/methodology