The system is designed for multi-body area muscle strengthening and can be operated simultaneously with other aesthetic treatments.
Sofwave Medical Ltd has received 510(k) premarket notification clearance from the US Food and Drug Administration (FDA) for its Pure Impact VIP, a standalone electrical muscle stimulation (EMS) device for muscle strengthening and firming.
The system is designed to be delegated and administered by clinical staff through a simple procedure. It features a tablet-based touch control and a six-channel configuration, allowing for the treatment of up to six muscle groups at once. As a standalone unit, it is intended to optimize practice workflow by enabling simultaneous treatments alongside other modalities, such as the company’s SUPERB system.
“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,” says Louis Scafuri, CEO of Sofwave Medical, in a release.
Addressing GLP-1 Patient Needs
The company highlights the device’s potential application for patients experiencing muscle loss associated with GLP-1 agonists. According to a report from McKinsey, 63% of GLP-1 patient respondents sought medical spa treatments, and a majority cited skin laxity as their primary concern.
“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,” Scafuri says in the release. “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.”
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