Ultrasonic body-contouring system

Intended purpose

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