# K122528: Ulthera System

- Pathway: 510(k) (Traditional)
- Applicant: Ulthera, Inc.
- Decided: Aug 28, 2012 after 8 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.
No later device cites it as a predicate yet.
0 of 2 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.

## Indications for use
The Ulthera® System is indicated for use as a non-invasive dermatological aesthetic treatment to: * lift the eyebrow

Source page: https://510kreport.com/device/K122528
Methodology: https://510kreport.com/methodology