# K260618: Ulthera® System

- Pathway: 510(k) (Traditional)
- Applicant: Ulthera, Inc.
- Decided: May 21, 2026 after 85 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: 8 generations back to K894834 (1989). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250418: Ulthera System (UC-1 Control Unit PRIME Model 2.1), Ulthera, Inc. (2025) Summary page 5.

## Indications for use
The Ulthera® System is intended to apply focused ultrasound energy to the body to achieve temporary changes in the physical appearance of the skin. 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. • improve the appearance of skin laxity on the abdomen, anterior arms, posterior arms, and knees 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/K260618
Methodology: https://510kreport.com/methodology