In a Category of its Own
The Ulthera system received U.S. FDA approval in 2009 through the de novo process, creating a new category of device. 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.
Over 14 Years in the Making...
The technology behind Ulthera was created through a research partnership formed in 1998 to develop micro-focused ultrasound for non-invasive treatment of liver cancer. In 2004, Ulthera was established to develop this technology for the aesthetic space. After two years of extensive pre-clinical research, Ulthera conducted 3 clinical studies to evaluate the safety and efficacy of the technology. One of these studies, an efficacy study at Northwestern University in 2007, demonstrated a clinically significant brow lift in 89% of the patients treated and led to Ulthera’s first FDA indication. In September 2009, Ulthera was granted de novo 510K clearance from the FDA, designating the device as a new category of non-invasive technology without a comparable predicate.
