# K243035: Ulthera® System

- Pathway: 510(k) (Traditional)
- Applicant: Ulthera, Inc.
- Decided: Feb 24, 2025 after 150 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: 6 generations back to K894834 (1989). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233996: Ulthera System (UC-1 Control Unit PRIME), Ulthera, Inc. (2024) Summary page 5.

## Most influential descendants
- K250418: Ulthera System (UC-1 Control Unit PRIME Model 2.1) (2025), 1 descendant of its own
- K260618: Ulthera® System (2026), 0 descendants of its own

## 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, and posterior arms 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/K243035
Methodology: https://510kreport.com/methodology