Ulthera® System

The Ulthera System is a non-invasive aesthetic device that applies focused ultrasound energy below the skin surface to create controlled thermal coagulation in the dermis, producing a lifting or tightening effect. It is indicated for treating skin laxity and wrinkles on the eyebrow, neck, décolleté, abdomen, and arms, and includes an optional imaging mode to visualize tissue depths up to 8 mm and ensure proper transducer coupling.

Both the subject and predicate devices use identical low-intensity, highly focused ultrasound technology with the same ultrasound signal energy and graphical user interface. They share identical main components (console, handpiece, transducers), identical dimensions and weight, and identical power specifications. The primary difference is a minor software update (version 2.1.2036 vs 2.1.2030) that allows user control of sound volume during treatment, verified through software validation testing.

ISO 10993-1 for biocompatibility of user-contacting components; IEC 60601-1 for electrical safety; FDA Guidance on Content of Premarket Submissions for Device Software Functions for software verification and validation using a basic documentation level.

The subject device shares the identical intended use, principle of operation, and technological foundation as the predicate—both deliver focused ultrasound to achieve temporary skin appearance improvements. The minor hardware and software differences (paint formulation and volume control feature) do not affect clinical functionality or performance specifications and have been validated through nonclinical testing. Additionally, seven clinical studies with 167 subjects demonstrated the device is safe and effective for the expanded indications (abdomen and arms), with no unexpected or severe adverse events, supporting that the expanded uses do not raise different safety or effectiveness questions.