The U.S. Food and Drug Administration (FDA) has cleared Ultherapy PRIME to improve the appearance of skin laxity on the knees — the first and only energy-based aesthetic device indicated for firming and tightening knee skin, according to its founder, Merz Aesthetics.
The treatment is designed to stimulate the body's natural collagen and elastin production, helping to improve skin firmness without surgery or downtime.
The federal approval reflects growing demand for non-invasive body rejuvenation procedures as clients increasingly seek skin firming and tightening solutions beyond the face and neck. Especially with the popularity of GLP-1 weight-loss medications that often result in overall skin laxity, industry observers have noted continued interest in body-focused aesthetic treatments.
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"Body aesthetics is no longer a secondary treatment category," says Patrick Urban, President of Merz Aesthetics North America. "There’s a stronger commercial demand and it's becoming central to how providers build their practices."
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With this latest FDA clearance, Ultherapy PRIME continues to expand its body treatment portfolio, beginning with a U.S. launch followed by a global rollout.
For medical spas and aesthetic practices, the new indication adds another option for addressing age-related skin concerns in an area that has historically had limited non-surgical treatment choices. It also highlights a broader trend toward treating body concerns with technology platforms that were initially developed for facial rejuvenation.
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Ultherapy PRIME builds on the legacy Ultherapy platform, which the company says has been used in more than 4 million treatments globally. For practices currentl using the legacy device, the announcement includes a transition plan.
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Merz Aesthetics plans to discontinue the Ultherapy legacy platform, with full service and support scheduled to conclude Sept. 30, 2027. The company says it will provide guidance and resources to providers during the transition.
