# K083629: Smoothshapes

- Pathway: 510(k) (Special)
- Applicant: Eleme Medical, Inc.
- Decided: Feb 19, 2009 after 73 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). 58 ancestors in all.
27 later devices descend from it; 1 cites it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053611: Smoothshapes, Bicellulase, Inc. (2006) Summary page 1.
- K061603: Smoothshapes, Biocellulase, Inc. (2006) Summary page 1.
- K071872: Velashape, Syneron Medical, Ltd. (2007) Summary page 1.

## Most influential descendants
- K100230: Smoothshapes System, 11318-120V, 11319-230V (2010), 26 descendants of its own
- K123971: Cynosure 1064NM Diode Laser (2013), 25 descendants of its own
- K150724: SculpSure (2015), 21 descendants of its own
- K150230: SculpSure (2015), 21 descendants of its own
- K160470: SculpSure (2016), 20 descendants of its own

## Indications for use
The Elem6 Medical SmoothShapes® system is indicated for the relief of minor muscle aches and pain, relief of muscle spasms, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K083629
Methodology: https://510kreport.com/methodology