Sofwave™ Granted FDA Clearance For Latest Innovation: The “Precise” SUPERB™ Applicator
Thursday, March 16, 2023
Sofwave Medical Ltd, an emerging leader in energy-based non-invasive, aesthetic medical devices for practitioners worldwide, announced today receipt of U.S. Food and Drug Administration (FDA) clearance of the Company’s 510(k) notification submission for its “Precise” compact SUPERB™ applicator to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions. The “Precise” applicator is also FDA cleared for short-term improvement in the appearance of cellulite.
“Following the recent FDA clearance of Sofwave’s SUPERB™ technology for the short-term improvement of cellulite last December, we are delighted to introduce the new “Precise” applicator to existing and prospective customers,” said Louis Scafuri, CEO of Sofwave Medical. “The compact applicator transducer array delivers the same safe and effective Synchronous Ultrasound Parallel Beam technology of existing large size applicators, but has been further refined with a condensed transducer configuration for more precise and convenient delivery of pulses around small, curved areas, such as the eyes and mouth. We expect this enhanced feature set and applicator configuration will be well received by Sofwave customers, and intend to leverage the new Precise applicator in additional indications in the future.”
Sofwave’s SUPERB™ System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves and an active cooling element that is used to cool the skin area in contact with the applicator’s transducers.
“We continue to add functional yet transformational feature sets to the initial SUPERB™ platform’s design,” said Dr. Shimon Eckhouse, Chairman & Co-Founder. “The Precise SUPERB ™ will enable treatment of hard to reach anatomical sites with the ability to accurately target the area of treatment and with a superior ergonomic design while delivering the same safe, comfortable and highly effective treatment.”