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].