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Ulthera® Receives First-Ever FDA Clearance for Non-invasive Lift of Skin on the Neck and Under the Chin

Posted on: March 1st, 2013 by csiaccess

Non-surgical Ultherapy® ultrasound procedure now used to tighten turkey necks and smooth out double-chins

Mesa, Ariz. – Oct. 10, 2012 – Ulthera, Inc. – a global, high-growth medical device company pioneering aesthetic and medical applications using its therapeutic ultrasound platform technology – today announced that its ultrasound platform device, the Ulthera System, has received FDA clearance to non-invasively lift lax tissue on the neck and the submental (under the chin).*

This is the second lift indication that the System has received; the first cosmetic lift indication was granted in 2009, when the Ulthera System was cleared as a facial treatment with a specific indication for non-invasive eyebrow lift.* To date, the Ulthera System remains the only energy-based device with an indication for lift.*
The Ulthera System – which combines time-honored ultrasound imaging with focused ultrasound therapy – is used in Ultherapy, a face and neck treatment with well over 100,000 patient procedures performed worldwide.*

“This latest validation of the Ulthera System and Ultherapy procedure is testament to the outcomes our clinicians report globally,” said Matthew Likens, president and CEO of Ulthera.* “We know from our customers and their patients that sagging skin under the chin and on the neck is a significant issue.* Patient demand for a non-invasive lift on the face and neck with just one treatment and no downtime is well established.”*

“As an FDA-cleared facial treatment for more than three years, many clinicians have noted improvements outside the indicated brow area,” said principal investigator Jeffrey Kenkel, M.D., Professor and Vice-Chairman of Plastic Surgery at UT Southwestern Medical Center.* “The ability to specifically claim lifting in another area, however, required solid quantitative data that would support noticeable and measurable outcomes in these areas.”*

“This clearance for the neck and under the chin is just one in a series of many new clinical indications we are pursuing in the years ahead,” Likens continued.* “Utilizing our tried-and-true ultrasound technology, our customers can expect to see continued investment by Ulthera to expand our platform technology’s treatment capabilities.”*

Photos “Before and After” the procedure are available for viewing:*

About Ulthera: Ulthera®, Inc. is a global, high-growth medical device company pioneering aesthetic and medical applications using its therapeutic ultrasound platform technology.* The Ulthera® System is the first and only energy-based device to receive FDA clearance for a non-invasive aesthetic lift indication.* It is used in a face and neck procedure known as Ultherapy®, which is cleared to lift skin on the brow, neck and under the chin.* Founded in 2004 and based in Mesa, Ariz., Ulthera is a privately held company backed by top-tier venture capital firms, New Enterprise Associates and Apposite Capital. For more information, visit*

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*Individual results may vary and are not guaranteed.

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