# K233996: Ulthera System (UC-1 Control Unit PRIME)

- Pathway: 510(k) (Special)
- Applicant: Ulthera, Inc.
- Decided: Feb 22, 2024 after 66 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: 5 generations back to K894834 (1989). 7 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K180623: Ulthera System, Ulthera, Inc. (2018) Summary page 5.

## Most influential descendants
- K243035: Ulthera® System (2025), 2 descendants of its own
- 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 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/K233996
Methodology: https://510kreport.com/methodology