Sofwave Precise SUPERB Applicator FDA Cleared for Improving Facial Lines, Wrinkles

Dermatology providers can now provide even more cosmetic enhancements for their patients such as improving facial lines and neck tissue with the Precise SUPERB applicator treatment following a US Food and Drug Administration (FDA) clearance.

Nicholas Felix, peopleimages.com/AdobeStock

Sofwave Medical Ltd, the medical device company that produces ultrasound technology, announced the clearance of its applicator in a press release.¹

The Precise SUPERB applicator is a multi-component device featuring both a console and applicator. The applicator uses ultrasonic transducer technology to emit both acoustic waves and a cooling element when in contact with a patient’s skin. SUPERB, or “Synchronous Ultrasound Parallel Beam” technology, is also FDA-cleared.²

The applicator has been cleared to treat facial lines and facial wrinkles. It is also cleared to lift the eyebrow and to lift neck tissue and beneath-the-chin tissue.

“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,” said Sofwave Chairman and Co-founder, Shimon Eckhouse, MD, in the press release.

Previously, the FDA had also recently cleared the applicator for its short-term improvement in treating patients with 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, Sofwave CEO, in the press release.

In the December press release² announcing the clearance of SUPERB technology, Sofwave shared details from its clinical trials.

Within the trials, 68 women across 4 United States sites participated. Every 2 to 4 weeks, participants received 2 SUPERB treatments on the lateral/posterior upper thigh or buttocks regions. 

Researchers photographed participants at the time of the trial’s initiation and 3 months after its conclusion. They measured improvement using both the Global Aesthetic Improvement and Laxity scales and assessed for safety and adverse events, of which none were reported.

Blinded reviewers later assessed the post-treatment photographs—89% of which were correctly identified.

“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,” said Eckhouse. “We expect this enhanced feature set and applicator configuration will be well received by Sofwavecustomers, and intend to leverage the new Precise applicator in additional indications in the future.”

References

1. SofWave Medical, Ltd. Sofwave granted FDA clearance for latest innovation: The "precise" SUPERB applicator. GlobeNewswire News Room. https://www.globenewswire.com/news-release/2023/03/15/2627894/0/en/Sofwave-Granted-FDA-Clearance-For-Latest-Innovation-The-Precise-SUPERB-Applicator.html. Published March 15, 2023. Accessed March 15, 2023.
2. SofWave Medical, Ltd. Sofwave medical announces FDA clearance of SUPERB Technology for cellulite. GlobeNewswire News Room. https://www.globenewswire.com/news-release/2022/12/19/2576317/0/en/Sofwave-Medical-Announces-FDA-Clearance-of-SUPERB-Technology-For-Cellulite.html. Published December 19, 2022. Accessed March 15, 2023.