On November 5, 2025, Merz Aesthetics announced that Ultherapy PRIME® gained U.S. Food and Drug Administration (FDA) clearance to improve the appearance of skin laxity on the anterior arms, posterior arms and abdomen. With these new clearance areas, the nonsurgical skin lifting treatment becomes the only FDA-cleared solution with real-time visualization to treat the face, neck, décolleté and body.

AmSpa spoke with Patrick Urban, President of Merz Aesthetics North America to discuss the new body indications and what they mean for the future of noninvasive aesthetics.

What does this FDA clearance mean for Merz Aesthetics and the Ultherapy brand?

The FDA clearance significantly expands the clinical reach of Ultherapy PRIME®, reinforcing its leadership in non-invasive skin lifting. Ultherapy PRIME is now FDA-cleared to improve the appearance of skin laxity on the anterior arms, posterior arms, and abdomen, making it the only FDA-cleared device with real-time visualization to treat the face**, neck, décolleté, and now the body*¹. This milestone builds on the brand’s legacy of over 3.5 million treatments performed globally and a 95% patient satisfaction rate, reflecting Merz Aesthetics’ continued investment in technologies that deliver personalized, natural-looking results.

How does Ultherapy PRIME reflect Merz Aesthetics’ broader commitment to innovation in non-invasive aesthetics?

Ultherapy PRIME exemplifies Merz Aesthetics’ commitment to innovation by enhancing both provider experience and patient outcomes. Ultherapy PRIME is the evolution of Ultherapy®, recognized as the Gold Standard for non-invasive skin lifting. Only Ultherapy PRIME combines an advanced microfocused ultrasound platform with 72% clearer, vivid real-time visualization, enabling healthcare professionals to precisely deliver energy exactly where it is needed most, resulting in 20% faster treatment times†. These advancements reflect a platform built for continued evolution and clinical relevance.

How should medical spas position Ultherapy PRIME in their treatment portfolios to maximize its potential?

Medical spas should position Ultherapy PRIME as a premium, non-invasive solution for both facial and body skin laxity. With the new body indications, it meets rising demand from patients experiencing skin laxity due to life stages like postpartum changes, menopause, or weight fluctuations, including those on weight loss therapies. The treatment’s appeal lies in its personalized, natural-looking results, and no downtime. By integrating Ultherapy PRIME into their offerings, medical spas can attract a broader patient base seeking subtle, long-lasting enhancements.

What would you like the broader aesthetic community to know about Merz Aesthetics’ brand portfolio and the staying power of non-invasive skin lifting tech, especially in light of shifting patient demographics with post-medical weight loss skin laxity?

Merz Aesthetics is committed to delivering clinically validated, non-invasive technologies that evolve with patient needs. The skin-lifting market is expanding rapidly and expected to grow approximately 9% CAGR by 2030, driven largely by life stage (postpartum, post-menopausal) and GLP-1 weight loss related skin laxity, as well as a growing male patient demographic. Ultherapy PRIME as well as other non-invasive treatments from Merz Aesthetics (i.e. injectables, biostimulatory dermal fillers) are uniquely positioned to address the growing demand with their ability to deliver personalized, natural-looking results. Ultherapy PRIME is a trusted solution for providers navigating demographic shifts and changing aesthetic preferences.

What is your vision for the next 5–10 years?

Over the next decade, Merz Aesthetics aims to continue expanding Ultherapy PRIME’s capabilities and indications, while advancing the broader field of non-invasive aesthetics. With its platform approach, Ultherapy PRIME is built for growth – offering visible, natural-looking results that can last up to a year or more on the face** and 6 months or more on the arms and abdomen*. The vision is to empower providers with tools that deliver precision, personalization, and proven outcomes, meeting patients where they are in their aesthetic journey.

The Ulthera® System is U.S. FDA-cleared to lift the eyebrow, the skin on the neck and under the chin as well as to improve lines and wrinkles on the décolleté and to improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms. The most common side effects reported in clinical trials were redness, swelling, pain and transient nerve effects. Reported adverse events from post-marketing surveillance are available in the Instructions for Use (IFU). Please see the IFU for product and safety information, including a full list of these events at Ultherapy.com/IFU.

¹Ulthera® Instructions for Use.
*Indicated to improve the appearance of skin laxity on the abdomen, anterior arms and posterior arms.
**Face refers to the FDA-cleared indications for Ultherapy PRIME.
† Average reported increase in system speed over legacy Ultherapy® device based on a survey of providers