Sofwave Receives FDA, Pre-market Clearance for Pure Impact VIPTM Standalone EMS Device For Comprehensive Multi-Body Area Muscle Strengthening and Firming
- The Pure Impact VIP™ standalone device represents a major extension of the Pure Impact™ product line and introduces an all-in-one independent unit
- Standalone device is launched with an enhanced Pure Impact™ feature set which provides comprehensive muscle strengthening programs that focus on multiple body areas including the: abdomen, arms, thighs, and buttocks and enables simultaneous treatment of 6 muscle groups
- In the recent McKinsey Life Sciences Practices report, 63% of GLP-1 patients seeking aesthetic services are new to the market and skin laxity was noted as the primary aesthetic patient concern
SAN CLEMENTE, Calif., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Sofwave Medical Ltd (“the Company”) (TASE: SOFW), an emerging leader in energy-based non-invasive, aesthetic medical devices, announced today that the Company has received 510(k) premarket notification clearance from the U.S. Food and Drug Administration (FDA). This clearance expands the Pure Impact™ product line further via the launch of a standalone EMS Device branded Pure Impact VIP™. The Pure Impact VIP™ is designed as a standalone system that can be delegated and administered by staff using a simple and intuitive procedure.
“Pure Impact VIP™ was created by popular demand from our customers, who asked for the ability to treat with both Sofwave and Pure Impact simultaneously while keeping pace with growing Sofwave SUPERB™ demand. This standalone system optimizes practice workflow and expands treatment flexibility. Just as important, Pure Impact VIP™ introduces a breakthrough tablet-based touch control and a 6-channel configuration that allows treatment of up to six muscle groups at once, setting a new standard in aesthetic device form factors—compact, intuitive, and performance-driven,” said Louis Scafuri, CEO of Sofwave Medical.
“This standalone platform brings the full power of our proprietary plyometric muscle activation technology into a compact, versatile unit that can be seamlessly integrated into all clinical practices. Whether used independently or alongside our SUPERB ultrasound system, Pure Impact VIP™ empowers providers to address the changing body contouring needs of aesthetic patients—especially those impacted by GLP-1–associated muscle loss—while enhancing visible tone and strength across multiple body zones.”
In McKinsey’s “GLP-1s are boosting demand for medical aesthetics” report, 63% of GLP-1 patient respondents sought medispa treatments, as first time aesthetic services seekers. In the same survey, most patients noted skin laxity as their primary concern in seeking aesthetic treatment services.
About Sofwave Medical
Sofwave Medical Ltd. has implemented an innovative approach to wrinkle reduction lifting and cellulite using its proprietary breakthrough technology. SUPERB™, Synchronous Ultrasound Parallel Beam technology, is FDA-cleared to improve facial lines and wrinkles, lifting the eyebrow and lifting lax submental tissue (beneath the chin), improving the appearance of skin laxity on the upper arms., as well as the short-term improvement in the appearance of cellulite and treatment of acne scars. The company’s Pure Impact™ module uses EMS technology and is cleared for muscle toning. Sofwave’s products provide physicians with smart yet simple, effective, and safe aesthetic solutions for their patients. Contact: Info@sofwave.com
Investor Contact:
Brian Ritchie
LifeSci Advisors LLC
(212) 915-2578
britchie@lifesciadvisors.com
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