New FDA clearance for SUPERB technology

16 Dec 2021

The SUPERB technology by aesthetic medical device company Sofwave Medical has received clearance by the US Food and Drug Administration (FDA).

The technology has been given clearance for lifting the eyebrow, lax submental tissue and neck tissue whilst its previously been cleared by the FDA for a non-invasive dermatological treatment to improve facial lines and wrinkles.

Sofwave Medical conducted a multi-site clinical study which evaluated the safety and effectiveness of the technology to lift the eyebrow, lax submental and neck tissue. A total of 80 subjects received treatments at five investigational sites in the US. A total of 467 facial areas were treated during the study.

Dr Shimon Eckhouse, chairman of the board of directors and co-founder of Sofwave Medical, said, “The FDA clearance represents another major achievement for the Sofwave platform and showcases Sofwave Medical’s ongoing focus on innovation and clinical advancements in energy-based technology. We will continue to develop innovative products that advance the medical aesthetics industry and meet the needs of our customers and the needs of their patients.”


Log-in to post a comment