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FDA Clears New Sofwave Technology for Muscle Toning 

The U.S. Food and Drug Administration has cleared Sofwave ‘s Pure Impact utilizing PlyoPulse electromagnetic stimulation (EMS) technology for muscle toning and strength conditioning.


The approval will allow practitioners to include toning and strengthening of diverse muscle groups along with eyebrow and submental neck lifting, treatment of fine lines and wrinkles, treatment of cellulite, and treatment of skin laxity with the SUPERB platform.

“Pure Impact with PlyoPulse technology is a modular add-on to Sofwave’s existing industry-leading medical device platform, allowing practitioners to immediately expand their spa or clinics’ suite of services,” says Louis Scafuri, CEO of Sofwave Medical, in a news release. “Moreover, this is a timely addition to our product line as the success and popularity of a new class of GLP-1 drugs in the marketplace intended for weight loss continues to shape the needs and demands of the aesthetics industry. “

About Pure Impact

Pure Impact stimulates multiple muscle groups and body areas simultaneously via PlyoPulse technology in a 30-minute treatment session. Advanced wireless connectivity provides treatment across multiple muscle groups without gels, liquids, or belts. Digital programming allows different treatment protocols to engage diverse muscle groups without the need to manually rearrange electrodes, thus avoiding treatment interruption. The Pure Impact treatment can be used in conjunction with the SUPERB system or as a stand-alone treatment.