Merz Aesthetics has received U.S. FDA clearance for Ultherapy PRIME® to improve the appearance of skin laxity on the knees, expanding the platform’s growing range of non-invasive body aesthetic applications. According to the company, the clearance makes Ultherapy PRIME the first energy-based aesthetic device indicated for treating skin laxity in the knee area.
The platform uses microfocused ultrasound with real-time visualization (MFU-V) to target multiple tissue depths and stimulate the body’s natural collagen and elastin production. With the new indication, Ultherapy PRIME can address skin laxity across the face, décolleté, abdomen, arms and knees, supporting a broader approach to non-surgical lifting and firming.
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The new clearance also reflects the growing focus on body aesthetics, as patients increasingly seek non-invasive options for areas beyond the face and neck. “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. He added that the launch is about “expanding the addressable market for non-invasive lifting and firming” as body aesthetics becomes increasingly important to aesthetic practices.
Ultherapy PRIME builds on the legacy of Ultherapy, which Merz says has been used in more than 4 million treatments globally. The company plans to launch the new knee indication in the U.S. before expanding it internationally. Merz is also transitioning away from the legacy Ultherapy device, with full service and support scheduled to conclude on September 30, 2027.
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