The addition of the Pure Impact module to Sofwave’s medical aesthetic device capabilities will allow practitioners to expand the opportunities beyond the existing client services using modular add-on technology to the SUPERB ultrasound platform


Pure Impact builds on the company’s existing SUPERB platform. (Credit: andreas160578 from Pixabay)

Sofwave Medical has received the US Food and Drug Administration (FDA) 510(k) approval to market its Pure Impact module for use with PlyoPulse EMS (electromagnetic stimulation) technology.

Pure Impact is a direct add-on body module to the company’s existing, FDA-approved medical aesthetic device platform, dubbed SUPERB (Synchronous Ultrasound Parallel Beam).

SUPERB technology can be used for eyebrow and submental neck lifting, treatment of fine lines and wrinkles, treatment of cellulite, and skin laxity.

PlyoPulse is an electrical muscle stimulation (EMS) technology intended to deliver toning and strengthening simultaneously across diverse muscle groups in a single treatment session.

The FDA approval of the Pure Impact module with PlyoPulse technology will help expand the medical aesthetic treatment beyond the SUPERB platform, said the medical devices maker.

Sofwave Medical CEO Louis Scafuri said: “The 510(k) clearance of Pure Impact allows Sofwave to bring to market a unique EMS device that can deliver muscle toning and strength conditioning simultaneously across diverse muscle groups in one treatment session.

“Pure Impact with PlyoPulse technology is a modular add-on to Sofwave’s existing industry-leading medical device platform, allowing practitioners to immediately expand their spa or clinics’ suite of services.”

Pure Impact is a unique system that stimulates multiple muscle groups and body areas simultaneously, to achieve intense muscle strengthening and toning.

Its modular add-on is said to redefine the toning with up to 16 synchronised electrodes, to achieve effective stimulation of large muscle groups.

Pure Impact can be used together with the SUPERB system or as a stand-alone treatment, to provide the same accurate energy delivery efficacy, safety, comfort, and results.

The PlyoPulse technology captures the efficacy of controlled muscle stimulation, eliminating the need for electrode rearrangement and delays in treatment time, all within 30 minutes.

Furthermore, the digital programming feature allows different treatment protocols to engage diverse muscle groups without the need to manually rearrange electrodes, said Sofwave.

Scafuri added: “Moreover, this is a timely addition to our product line as the success and popularity of a new class of GLP-1 drugs in the marketplace intended for weight loss continues to shape the needs and demands of the aesthetics industry.

“We are delighted to begin the initial commercial launch of Pure Impact in the US in the near term while working to bring this product to other geographies as expeditiously as possible.”