Pure Impact™
Search documents
Sofwave Receives FDA, Pre-market Clearance for Pure Impact VIPTM Standalone EMS Device For Comprehensive Multi-Body Area Muscle Strengthening and Firming
Globenewswire· 2025-09-04 12:30
Core Insights - Sofwave Medical Ltd has received FDA 510(k) premarket notification clearance for its new standalone EMS device, Pure Impact VIP™, expanding its product line and enhancing treatment options for aesthetic medical practices [1][5]. Company Developments - The Pure Impact VIP™ device was developed in response to customer demand for simultaneous treatment capabilities with Sofwave and Pure Impact, optimizing workflow and treatment flexibility [2][5]. - The device features a tablet-based touch control and a 6-channel configuration, allowing treatment of up to six muscle groups simultaneously, setting a new standard in aesthetic device design [2][5]. Industry Context - The introduction of Pure Impact VIP™ addresses the growing demand for aesthetic treatments, particularly among patients experiencing muscle loss associated with GLP-1 medications, with 63% of GLP-1 patients seeking aesthetic services being first-time users [3][5]. - Skin laxity is identified as the primary concern for patients seeking aesthetic treatments, highlighting a significant market opportunity for the company's offerings [3][5].
Sofwave’s liftHD Body Contouring Applicator to Debut at the 44th Annual Meeting of the American Society for Laser Medicine and Surgery (ASLMS) 2025
Globenewswire· 2025-04-24 12:30
Core Insights - Sofwave Medical Ltd has launched the liftHD high density body contouring handpiece, enhancing non-invasive aesthetic body treatments for cellulite and skin laxity, aiming for superior results beyond facial applications [1][2] - The company is showcasing its products at the ASLMS 2025 conference, emphasizing the growing demand for non-invasive treatments driven by the popularity of GLP-1 medications [2] - Sofwave's SUPERB™ technology is highlighted for its precise thermal treatment capabilities, optimizing energy delivery for effective results [3][4] Product Launch and Features - The liftHD applicator utilizes the same SUPERB™ pulse technology as existing products but offers broader thermal zones, reducing treatment time by approximately 40% [2] - The applicator is designed for user-friendliness and efficiency, providing comfortable treatments [2] - The technology allows for precise depth control and optimized energy delivery, achieving dermal stimulation at temperatures between 149-158°F [3] Clinical Evidence and Presentations - Four abstract poster presentations will be featured at ASLMS 2025, showcasing clinical applications of Sofwave's technology [4][5][6][7] - The presentations cover various topics, including treatments for melasma, inflammatory acne, cellulite improvement, and peri-oral rhytides [5][6][7] Company Overview - Sofwave Medical Ltd focuses on innovative solutions for wrinkle reduction, lifting, and cellulite treatment using its proprietary SUPERB™ technology, which is FDA-cleared for multiple aesthetic applications [8]