Merz Aesthetics Announces FDA Clearance of Ultherapy PRIME for Knee Skin Laxity

The US Food and Drug Administration (FDA) has cleared Ultherapy PRIME (Merz Aesthetics) to improve the appearance of skin laxity on the knees, according to an announcement from the company.

Merz Aesthetics said the clearance makes Ultherapy PRIME the first energy-based aesthetic device with an indication for this treatment area. The new indication expands the platform’s body applications, which include lifting and firming skin on the abdomen and arms.

"The skin-lifting market is expanding rapidly and expected to grow approximately 9% CAGR by 2030, driven largely by life stage (post-partum, post-menopausal) and weight-loss-related skin laxity," Patrick Urban, president of Merz Aesthetics North America, told Modern Aesthetics. "Patients are gravitating toward non-invasive treatments that deliver personalized, natural-looking results and enhance their appearance without dramatic changes. This new indication makes Ultherapy PRIME the first and only energy-based aesthetic device to receive FDA clearance to treat the highly visible knee area, enabling providers to better meet patient demand for integrated solutions that address both face and body."

Ultherapy PRIME Expands Body Skin Laxity Indications

Ultherapy PRIME uses microfocused ultrasound with real-time visualization (MFU-V), allowing clinicians to visualize tissue and deliver treatment at multiple skin depths. According to Merz Aesthetics, the technology is designed to stimulate collagen and elastin production and is intended to provide nonsurgical lifting and firming.

“Being the first to bring FDA-cleared real-time visualization to the knees represents a meaningful milestone,” Urban said in the announcement. He added that the expanded indication comes amid growing commercial interest in nonsurgical body aesthetic procedures.

Jennifer Levine, MD, a facial plastic surgeon in New York City, said interest in treating areas beyond the face and neck has increased as patients become more familiar with aesthetic treatment options.

“The knees are a common concern for patients who have skin laxity in this area as their skin loses collagen and elastin with age,” Levine said.

The clearance adds to existing Ultherapy PRIME indications involving the face, décolleté, abdomen, and arms, according to Merz Aesthetics.

The company also announced that it is transitioning away from its legacy Ultherapy device. Full service and support for that system are scheduled to conclude September 30, 2027.