Sofwave Medical’s Ultrasound Technology Receives FDA Clearance

The FDA clearance is for the aesthetic treatment of facial lines and wrinkles. Photo Credit: ValuaVitaly/iStock/Getty Images Plus

Sofwave Medical, an emerging aesthetic device company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sofwave system. The Sofwave device is indicated for use as a non-invasive aesthetic treatment to improve facial lines and wrinkles. The 510(k) clearance was supported by a study of 59 subjects which showed that 86 percent of the subjects demonstrated improvement in wrinkle appearance of at least one Elastosis Score (-1ES), and blinded reviewers identified correctly the pre- and post-treatment photographs for 78 percent of the treated subjects. "Receiving FDA clearance for the Sofwave technology is an important milestone for the company as it opens our product to the large market in the United States,” says Louis Scafuri, CEO of Sofwave Medical. “Our breakthrough non-invasive ultrasound technology targets a growing customer base of patients who are looking to reduce their wrinkles and facial lines, but did not wish to consider surgery. We believe that our device addresses this demand across broad demographics.”


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