# K053611: Smoothshapes

- Pathway: 510(k) (Traditional)
- Applicant: Bicellulase, Inc.
- Decided: Mar 15, 2006 after 78 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.
95 later devices descend from it; 4 cite it directly.
0 of 150 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.
- K050397: Velasmooth, Shaper, Syneron Medical, Ltd. (2005) Summary page 1.

## Most influential descendants
- K061603: Smoothshapes (2006), 48 descendants of its own
- K082622: Alma Lasers Accent B-Shape Massager Handpiece/Module (2009), 45 descendants of its own
- K083629: Smoothshapes (2009), 27 descendants of its own
- K100230: Smoothshapes System, 11318-120V, 11319-230V (2010), 26 descendants of its own
- K123971: Cynosure 1064NM Diode Laser (2013), 25 descendants of its own

## Indications for use
The Biocellulase SmoothShapes device 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/K053611
Methodology: https://510kreport.com/methodology