Has Ultherapy been approved by the FDA to use on whole face?

Question

I noticed that FDA only approved Ultherapy to use above brow and under chin. Not sure it is safe to use on whole face. Thx for your answer.

Ron Shelton, MD · Answer

Once a device is FDA cleared for a certain use, physicians may use it for off-label uses in many cases.- 2009, FDA clearance for brow lifting- 2012 FDA indication for neck and under-chin lift- 2013 it received a third FDA indication for visualization of dermal and subdermal tissue layers.- Most recently, the system received its fourth FDA indication for improvement of lines and wrinkles on the décollete (chest) But, no, there is no specific indication for cheeks but the software actually illustrates the cheek patterns and the company trains doctors exactly how to treat these areas.The information provided in Dr. Shelton's answer is for educational purposes only and is not intended to constitute medical advice.  The information provided should not be relied upon as a substitute for consultations with a qualified health professional who may be familiar with your individual medical needs.

Laurie A. Casas, MD, FACS · Answer

Thank you for question.  Ultherapy is a FDA cleared non-invasive facelift procedure to rejuvenate and tighten skin on the face, forehead, neck and décolletage. Ultherapy treatments improve wrinkles on the face, forehead, neck and décolletage with no downtime. Ultherapy works by administering ultrasound energy to specific depths of skin and muscle with precise ultrasound guidance, which causes tissue tightening and collagen production.  New collagen production is generated over 2-3 months and often continues for 6 months after the treatment. Full results are visible after 3 to 6 months. To optimize your results Dr. Casas will recommend an appropriate diet, supplements and topical skin care regimen.

Has Ultherapy been approved by the FDA to use on whole face?

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Has Ultherapy been approved by the FDA to use on whole face?

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