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SofWave Medical's Low-divergence Ultrasound Technology Receives FDA Clearance for Aesthetic Uses

Friday, September 20, 2019   (0 Comments)
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Sofwave Medical Ltd., 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 blinded study of 59 subjects, demonstrating the safety and performance of the Sofwave System for non-invasive treatment to improve facial lines and wrinkles. The trial was led by principal investigators Dr. Roy Geronemus, New York, and Dr. Arielle Kauvar, New York.

Read more at PR Newswire >>


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