Merz Aesthetics said the U.S. Food and Drug Administration has cleared Ultherapy PRIME to improve the appearance of skin laxity on the knees, giving the platform a new treatment area as demand grows for non-invasive aesthetics beyond the face and neck.
The company said the clearance makes Ultherapy PRIME the first and only energy-based aesthetic device indicated for knee treatments. The move adds to the platform’s cleared body indications, which already include lifting the face, smoothing the décolleté, and firming and lifting the skin on the abdomen and arms.
Knees have become a growing focus in aesthetics discussions, according to the company, driven by trends around "Hollywood knees" and interest in non-invasive options for areas outside the face and neck.
Ultherapy PRIME is built on the legacy of Ultherapy and uses microfocused ultrasound with vivid real-time visualization, or MFU-V. Merz Aesthetics said the device treats multiple skin depths so practitioners can tailor treatment to a patient’s anatomy. The company also said the treatment works by stimulating the body’s natural collagen and elastin production, typically requires a single session with no downtime, and is safe for all skin tones.
"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."
Merz Aesthetics framed the clearance as part of a broader expansion for the Ultherapy PRIME platform.
"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."
The company said Ultherapy PRIME builds on Ultherapy, which it described as the Gold Standard in non-invasive skin lifting, with more than 4 million treatments performed globally and 95% patient satisfaction at year one.
Outside the company, physicians are also seeing broader patient interest in treatment areas beyond the traditional focus of facial aesthetics.
"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."
Merz Aesthetics also said it will transition away from the legacy Ultherapy device, with full service and support concluding on September 30, 2027, as Ultherapy PRIME continues to expand its role in nonsurgical skin lifting.
