The Ulthera system received U.S. FDA approval in 2009 through the de novo process, creating a new category of devices. It is the first and only non-invasive technology to receive an FDA indication for lift. Unlike traditional laser and radio-frequency devices that heat tissue through the skin’s surface, Ultherapy delivers micro-focused ultrasound energy below the skin’s surface. This targets the foundational layers of the skin, precisely heating tissue to the optimal temperature for neocollagenesis (>60°C), without affecting the epidermis. Significant results, including skin tightening and lifting, can be achieved from a single 60-minute session, with no patient downtime.

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