FDA Clears Ultherapy PRIME for Skin Laxity on Arms, Abdomen

The US Food and Drug Administration (FDA) has cleared Ultherapy PRIME for the treatment of skin laxity on the anterior arms, posterior arms, and abdomen, according to Merz Aesthetics. The device is now FDA-cleared for noninvasive lifting and firming of the face, neck, décolleté, and body.

Ultherapy PRIME delivers micro-focused ultrasound with real-time visualization and is indicated for use in patients seeking noninvasive skin tightening. According to Merz Aesthetics, the clearance extends the utility of the system to areas of the body with limited noninvasive treatment options.

“This expanded FDA clearance is a testament to our unwavering commitment to advancing innovation that puts patients first,” said Patrick Urban, President, Merz Aesthetics North America. “Building on last year’s successful US Ultherapy PRIME launch, we are extending this trusted, proven technology to address a gap in the market and meet customer and patient needs. With these new body indications, providers now have an advanced and trusted device to address the root cause of skin laxity and help achieve personalized firming in the arms and abdomen.”

Ultherapy PRIME builds on the legacy of Ultherapy, which Merz reports has been used in more than 3.5 million treatments worldwide and holds a patient satisfaction rate of 95%. The technology is designed to stimulate neocollagenesis and elastin production in a single session with no downtime. The company states results can last up to 12 months on the face and at least 6 months on the arms and abdomen.

Ultherapy PRIME has been a cornerstone in my practice for lifting the skin of the face and neck,” said Dr. Jennifer Levine, a double board-certified facial plastic surgeon in New York City. “I’m excited to offer patients a noninvasive option to firm and tone the arms and abdomen—places where noninvasive solutions were once limited. The ability to visualize tissue in real time and target collagen-rich layers sets Ultherapy PRIME apart, delivering results patients can truly see and feel.”

Merz announced that support for the legacy Ultherapy platform will conclude on September 30, 2027. Practices using the original system will be provided with resources and guidance during the transition period.