# DEN080006: Ulthera System, Model 8850-0001

- Pathway: De Novo (Post-NSE)
- Applicant: Ulthera, Inc.
- Decided: Sep 11, 2009 after 518 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
No predicates in its family tree.
36 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K121700: Ulthera System (2012), 17 descendants of its own
- K132028: Ulthera System (2013), 16 descendants of its own
- K100874: Liposonix System, Model 1 P00XXXX (2011), 16 descendants of its own
- K134032: Ulthera System (2014), 15 descendants of its own
- K112626: Lipsonix (R) System Model 2 (2011), 15 descendants of its own

Source page: https://510kreport.com/device/DEN080006
Methodology: https://510kreport.com/methodology