# K170370: Ultrashape Power System

- Pathway: 510(k) (Traditional)
- Applicant: Syneron Medical, Ltd.
- Decided: May 15, 2017 after 98 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: 6 generations back to DEN080006 (2009). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162163: UltraShape System, Syneron Medical, Ltd. (2016) Summary page 4.
- K161952: UltraShape System, Syneron Medical, Ltd. (2016) Summary page 4.
- K160896: Ultrashape Power System, Syneron Medical, Ltd. (2016) Summary page 4.

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

Source page: https://510kreport.com/device/K170370
Methodology: https://510kreport.com/methodology