Sofwave Medical Ltd. announced clearance by the U.S. Food and Drug Administration (FDA) for the Company's 510(k) premarket notification submission to market Pure Impact?? utilizing PlyoPulse?? EMS ("electromagnetic stimulation") technology in the United States.

The approval clears a pathway for Sofwave to expand medical aesthetic treatment beyond the Company's existing SUPERB?? platform for eyebrow and submental neck lifting, treatment of fine lines and wrinkles, treatment of cellulite, and treatment of skin laxity to now allow practitioners to include body toning and strength conditioning across diverse muscle groups in one treatment session.