# K112626: Lipsonix (R) System Model 2

- Pathway: 510(k) (Special)
- Applicant: Medicis Technologies Corporation
- Decided: Oct 20, 2011 after 41 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: 2 generations back to DEN080006 (2009). 2 ancestors in all.
15 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100874: Liposonix System, Model 1 P00XXXX, Medicis Technologies Corporation (2011) Summary page 1.

## Most influential descendants
- K133238: Contour I V3.1 System (2014), 11 descendants of its own
- K141708: Ultrashape System (2014), 10 descendants of its own
- 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

## Indications for use
The LipoSonix system delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to achieve a desired. aesthetic effect. The LipoSonix system is specifically indicated for non-invasive waist circumference reduction.

Source page: https://510kreport.com/device/K112626
Methodology: https://510kreport.com/methodology