# K100874: Liposonix System, Model 1 P00XXXX

- Pathway: 510(k) (Traditional)
- Applicant: Medicis Technologies Corporation
- Decided: Aug 19, 2011 after 507 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: 1 generation back to DEN080006 (2009). 1 ancestor in all.
16 later devices descend from it; 1 cites 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)
- DEN080006: Ulthera System, Model 8850-0001, Ulthera, Inc. (2009). Our reading of the summary gave K072505, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN080006, Ulthera System, Model 8850-0001 (Ulthera, Inc.), granted Sep 11, 2009; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K112626: Lipsonix (R) System Model 2 (2011), 15 descendants of its own
- 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

## 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/K100874
Methodology: https://510kreport.com/methodology