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.”