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# FDA Clears Sofwave Wrinkle-treating Ultrasound
- URL: https://www.fdaweb.com/fda-clears-sofwave-wrinkle-treating-ultrasound/
- Published: 2019-09-18T12:00:00.000Z
- Updated: 2026-09-15T01:50:35.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145038

FDA has cleared a Sofwave Medical 510(k) for its Sofwave system, indicated for use as an esthetic (XXX SPELLING XXX)treatment to improve facial lines and wrinkles. The company says the clearance was supported by a blinded study in 59 subjects. According to the investigators’ evaluation, 86% of the subjects demonstrated improvement in wrinkle appearance, and blinded reviewers identified correctly the pre- and post-treatment photographs for 78% of treated subjects, it says. The device uses the company’s patented, low-divergence fractional ultrasound technology.