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FDA approves Ulthera System for noninvasive treatment of neck, submental tissue
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ATLANTA — The Ulthera System received this week its second FDA clearance for noninvasive ultrasound treatment of neck and submental skin laxity and follows its 2009 approval for noninvasive eyebrow lift, according to the manufacturer.
“As an FDA-cleared facial treatment for more than 3 years, many clinicians have noted results outside the indicated brow area,” principal investigator Jeffrey Kenkel, MD, professor and vice chairman of plastic surgery at University of Texas Southwestern Medical Center, said in a Ulthera press release. “The ability to specifically claim lifting in another area, however, required solid quantitative data that would support noticeable and measurable results in these areas.”
According to the release, the Ulthera System is the “only energy-based device with indication for lift.”
“This latest validation of the Ulthera System and Ultherapy procedure is testament to the results our clinicians report globally,” said Matthew Likens, Ulthera president/CEO. “Patient demand for a noninvasive lift on the face and neck with just one treatment and no downtime is well established.” — by Joan-Marie Stiglich