# K160896: Ultrashape Power System

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Jul 8, 2016 after 99 days
- Product code: OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption)
- Device class: 2
- Regulation: 21 CFR 878.4590
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN080006 (2009). 5 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141708: Ultrashape System, Syneron Medical, Ltd. (2014) Summary page 4.
- K133238: Contour I V3.1 System, Syneron Medical, Ltd. (2014) Summary page 4.

## Most influential descendants
- K191696: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft (2019), 4 descendants of its own
- K202430: Kerecis Reconstruct (2021), 3 descendants of its own
- K251844: Kerecis SurgiBind (50241) (2025), 0 descendants of its own
- K251224: Restrata Soft Tissue Reinforcement (STR) (2025), 0 descendants of its own
- K243843: Tendon Protect (50242) (2025), 0 descendants of its own

## Indications for use
The UltraShape Power System delivers focused ultrasound energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired aesthetic effect. It is intended for non-invasive reduction in abdominal circumference.

Source page: https://510kreport.com/device/K160896
Methodology: https://510kreport.com/methodology