# K180623: Ulthera System

- Pathway: 510(k) (Traditional)
- Applicant: Ulthera, Inc.
- Decided: May 4, 2018 after 56 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: 4 generations back to K894834 (1989). 6 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K134032: Ulthera System, Ulthera, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K230820: SofWave System (2023), 5 descendants of its own
- K232455: SofWave System (2023), 4 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; which can also affect the appearance of lax tissue in the submental and neck regions • improve lines and wrinkles of the décolleté 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/K180623
Methodology: https://510kreport.com/methodology