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With this latest FDA clearance, Ultherapy PRIME continues to expand its non-surgical body treatment portfolio, beginning with a U.S. launch followed by a global rollout.

The knees are a highly visible area of concern for patients, as their skin loses collagen and elastin with age. The U.S. Food and Drug Administration recently cleared Ultherapy PRIME to treat the appearance of skin laxity on the knees.
Merz Aesthetics
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Once an overlooked treatment area, knees have become one of aethetics' fasterst growing conversation starters, fueled by trends around "Hollywood knees" and the desire for non-invasive treatments for areas beyond the face and neck.
Merz Aesthetics, one of the world’s largest dedicated medical aesthetics business, recently announced that the U.S. Food and Drug Administration (FDA) has cleared Ultherapy PRIME to improve the appearance of skin laxity on the knees. With this clearance, the platform becomes the first and only energy-based aesthetic device indicated for this treatment area.
This milestone marks a significant expansion of Ultherapy PRIME’s growing portfolio of cleared body indications. Built on the legacy of Ultherapy, the world’s #1 energy-based aesthetic device, and powered by advanced microfocused ultrasound with vivid real-time visualization (MFU-V), the platform now offers a comprehensive approach to addressing skin laxity with indications to lift the face, smooth the décolleté, and firm and lift the skin on the abdomen, arms, and knees.
"Being the first to bring FDA-cleared real-time visualization to the knees represents a meaningful milestone," said Patrick Urban, President of Merz Aesthetics North America. "However, this launch is about more than a new indication; it’s about expanding the addressable market for non-invasive lifting and firming. Body aesthetics is no longer a secondary treatment category – there’s a stronger commercial demand and it's becoming central to how providers build their practices. Merz Aesthetics is well-positioned to continue to lead that shift here in the U.S.”
Ultherapy PRIME treats multiple skin depths, allowing practitioners to tailor treatment to each patient’s unique anatomy. By stimulating the body’s natural collagen and elastin production, it delivers a non-surgical lift with natural-looking, long-lasting results for the face and body. Designed with patient convenience in mind, it typically requires a single session with no downtime and is safe for all skin tones.
“The new knees indication marks another monumental moment for Ultherapy PRIME,” said Dr. Samantha Kerr, Chief Scientific Officer at Merz Aesthetics. “It underscores our commitment to advancing science-backed innovation and expanding non-invasive treatment possibilities for healthcare professionals and their patients.”
Ultherapy PRIMEbuilds on the proven legacy of Ultherapy, recognized as the Gold Standard in non-invasive skin lifting, with more than 4 million treatments performed globally and 95% patient satisfaction at year one.
“As patients become more informed about aesthetic treatment options, we’re seeing increasing interest in areas beyond the face and neck,” said Dr. Jennifer Levine, double board-certified facial plastic surgeon in New York City. “The knees are a common concern for patients who have skin laxity in this area as their skin loses collagen and elastin with age. The advancement of Ultherapy PRIME for the knees represents an important advancement and personalized approach to addressing these concerns and growing patient demand.”
As Ultherapy PRIME continues to redefine the future of nonsurgical skin lifting, Merz Aesthetics will transition away from the legacy Ultherapy device, with full service and support concluding on September 30, 2027. Merz Aesthetics is committed to ensuring a smooth transition and will provide guidance and resources throughout the process.
To learn more about Ultherapy PRIME, visit Ultherapy.com and follow @Ultherapy on Instagram.
Ultherapy PRIME is a non-surgical body treatment developed by Merz Aesthetics, recently FDA-approved for use on knees.
*Summarized by AI

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