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.
