# K141708: Ultrashape System

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: Oct 6, 2014 after 104 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: 4 generations back to DEN080006 (2009). 4 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K160896: Ultrashape Power System (2016), 6 descendants of its own
- 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
- K162163: UltraShape System (2016), 1 descendant of its own
- K161952: UltraShape System (2016), 1 descendant of its own

## Indications for use
The UltraShape 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/K141708
Methodology: https://510kreport.com/methodology