Merz Aesthetics’ Ultherapy PRIME Gains FDA Clearance for Knee Skin Laxity

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, making it the first and only energy-based aesthetic device with an indication for this treatment area. The new clearance expands the platform’s growing portfolio of body applications and marks another step in the industry’s increasing focus on nonsurgical body rejuvenation.

Ultherapy Prime uses microfocused ultrasound with real-time visualization (MFU-V) to stimulate collagen and elastin production in targeted tissue layers. With the addition of the knee indication, the platform is now cleared to lift the face, smooth the décolleté, and firm and lift skin on the abdomen, arms, and knees.

Merz executives positioned the clearance as both a clinical and business milestone, citing growing consumer interest in treating signs of aging beyond the face and neck. The company said body aesthetics continues to emerge as a significant growth category for aesthetic practices, creating new opportunities for providers to address patient concerns with noninvasive treatments.

Age-related collagen and elastin loss can contribute to skin laxity and crepiness in the knee area, which may become more noticeable in this area because the skin is relatively thin and subject to frequent movement. As patients increasingly seek more comprehensive rejuvenation approaches, knee laxity is becoming part of broader aesthetic treatment discussions.

“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 a release. “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.”

Ultherapy Prime launched in 2024 as the next-generation version of Ultherapy and is the only FDA-cleared noninvasive ultrasound platform with real-time imaging designed to help practitioners visualize tissue during treatment. Merz reported that the platform builds on the legacy of Ultherapy, which has been used in more than 4 million of treatments worldwide.