# K132028: Ulthera System

- Pathway: 510(k) (Traditional)
- Applicant: Ulthera, Inc.
- Decided: Dec 11, 2013 after 163 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 K894834 (1989). 4 ancestors in all.
16 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121700: Ulthera System, Ulthera, Inc. (2012) Summary page 1.
- K983945: Cortex Dermascan C Ultrasonic System, Cortex Technology Aps (1999) Summary page 1.

## Most influential descendants
- K134032: Ulthera System (2014), 15 descendants of its own
- K180623: Ulthera System (2018), 13 descendants of its own
- K211483: SofWave System (2021), 8 descendants of its own
- K223237: SofWave System (2022), 7 descendants of its own
- K230019: SofWave System (2023), 6 descendants of its own

## Indications for use
The Ulthera System is indicated for use as a non-invasive dermatological aesthetic treatment to: lift the eyebrow lift lax submental (beneath the chin) and neck tissue The Ulthera System in conjunction with the Ulthera DeepSEE transducer allows for ultrasonic visualization of depths up to 8 mm below the surface of the skin. The indicated use of the imaging is to visualize the dermal and subdermal layers of tissue to: ensure proper coupling of the transducer to the skin confirm appropriate depth of treatment such as to avoid bone

Source page: https://510kreport.com/device/K132028
Methodology: https://510kreport.com/methodology