On August 11, 2026, Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced that the U.S. Food and Drug Administration (FDA) cleared their Ultherapy PRIME device 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, further expanding its leadership as the first and only FDA-cleared ultrasound with real-time visualization for non-surgical skin lifting.
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.
“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.”
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.
