The FDA has cleared Merz Aesthetics’ Ultherapy PRIME to improve the appearance of skin laxity on the knees, expanding the device’s body indications.
Merz Aesthetics announced that the U.S. Food and Drug Administration (FDA) has cleared Ultherapy PRIME to improve the appearance of skin laxity on the knees. According to the company, the clearance makes Ultherapy PRIME the first energy-based aesthetic device indicated for this treatment area.
Ultherapy PRIME Expands Body Indications
The knee clearance expands the body indications for Ultherapy PRIME, which uses microfocused ultrasound with real-time visualization. The platform also has indications to lift areas of the face, smooth the décolleté, and firm and lift skin on the abdomen and arms.
“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.”
Treatment Targets Multiple Skin Depths
Ultherapy PRIME treats multiple skin depths, allowing practitioners to tailor treatment based on patient anatomy. The treatment stimulates collagen and elastin production and typically requires a single session with no downtime, according to Merz Aesthetics. The company states that the treatment can be used on 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 PRIME builds on the company’s previous Ultherapy device. Merz Aesthetics reports that more than 4 million Ultherapy treatments have been performed globally and that patient satisfaction is 95% at one year.
Knee Skin Laxity as a Treatment Area
“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 Plans Ultherapy Transition
Merz Aesthetics also announced that it will transition away from the legacy Ultherapy device. Full service and support for that device will conclude on September 30, 2027. The company said it will provide guidance and resources during the transition.
Photo: Merz Aesthetics
