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Merz Aesthetics Unveils Ultherapy PRIME FDA-Cleared for Arms, Abdomen With Real-Time Ultrasound Visualization

Latest FDA Clearance Expands to Improve the Appearance of Skin Laxity on the Anterior Arms, Posterior Arms and Abdomen, to launch in the United States before worldwide expansion.
´º½ºÀÏÀÚ: 2025-12-10

RALEIGH, N.C. -- Merz Aesthetics, the world’s largest dedicated medical aesthetics business, announced the U.S. Food and Drug Administration (FDA) clearance of Ultherapy PRIME to improve the appearance of skin laxity on the anterior arms, posterior arms and abdomen.

Ultherapy PRIME is the only FDA-cleared solution with real-time visualization to treat the face**, neck, décolleté and now body*.[1] The new indications will launch in the U.S. before expanding to markets worldwide.

“This FDA clearance is proof of our incredible momentum, following last year’s successful Ultherapy PRIME launch,” said Bob Rhatigan, CEO, Merz Aesthetics. “By extending our reach from face** to body*, we’re unlocking new treatment possibilities, meeting rising patient demand, and reinforcing our leadership in non-invasive skin lifting and firming.”

Ultherapy PRIME builds on the legacy of Ultherapy®, which is recognized as the Gold Standard in non-invasive skin lifting with over 3.5 million treatments performed globally and a 95% satisfaction rate.[1-3] The skin lifting market is expanding rapidly and is expected to grow approximately 9% by 2030, driven largely by life stage (post-partum, menopause), and weight loss related skin laxity patient demographics.[4]

Ultherapy PRIME stimulates the body’s natural collagen and elastin production precisely where it’s needed. In just one session, Ultherapy PRIME lifts the brows, the skin under the chin and on the neck, and smooths lines and wrinkles on the décolleté. Now, Ultherapy PRIME also firms and tones the skin on the arms and abdomen - with no downtime and safe for all skin types. [1,5] It offers personalized, visible natural-looking results, along with younger looking skin, that can last up to a year or more on the face** and 6 months or more on the arms and abdomen.[4-7]

“The Ultherapy PRIME platform offers all the signature benefits of Ultherapy for non-invasive skin lifting, plus the ability to improve the quality of skin on the abdomen and arms in a single session,” said Sabrina Fabi, MD, world-renowned, Double Board-Certified Dermatologist and Dermatological Cosmetic Surgeon from San Diego, California. “This is of great value for my patients who want to keep the skin on their body looking as youthful as the skin on their face.”[6,8,9]

“These new indications for arms and abdomen* strengthen Ultherapy PRIME’s position as a multi-purpose skin lifting, smoothing and firming treatment solution,” said Alexis Stern, Chief Marketing Officer, Merz Aesthetics. “This exciting journey started a year ago when we launched Ultherapy PRIME as a platform to lift the face**, and with this next phase of growth we are able to firm and tone the body*.”[1,8]

References:

[1] Ulthera® Instructions for Use.
[2] Werschler WP, Werschler PS. Long-term efficacy of micro-focused ultrasound with visualization for lifting and tightening lax facial and neck skin using a customized vectoring treatment method. J Clin Aesthet Dermatol. 2016;9(2):27-33.
[3] Ultherapy PRIME Letter of Treatments Sold. Merz Aesthetics®, Herring L, Sr Director, Regulatory Affairs, Advertising and Promotion. July 16, 2025. Data on File.
[4] Data on File. Merz Custom Market Forecasting 2025.
[5] Marquardt K, Hartmann C, Wegener F, et al. Microfocused ultrasound with visualization induces remodeling of collagen and elastin within the skin. J Cosmet Dermatol. 2025;24(1):e16638. doi:10.1111/jocd.16638.
[6] Fabi SG, Joseph J, Sevi J, Green JB, Peterson JD. Optimizing patient outcomes by customizing treatment with microfocused ultrasound with visualization: gold standard consensus guidelines from an expert panel. J Drugs Dermatol. 2019;18(5):426-432.
[7] Park JY, et al. Customized Treatment Using Microfocused Ultrasound with Visualization for Optimized Patient Outcomes: A Review of Skin tightening Energy Technologies and a Pan-Asian Adaptation of the Expert Panel’s Gold Standard Consensus. J Clin Aesthet Dermatol. 2021;14(5): E70-E79.
[8] Sasaki G, Grossman J, Fabi SG, et al. Stimulation of Collagen Synthesis in Human Skin Following Microfocused Ultrasound Therapy. Presented at the ASDS 2018 Annual Meeting.
[9] Goldie K, Kerscher M, Fabi SG, Hirano C, Landau M, Lim TS, Woolery-Lloyd H, Mariwalla K, Park JY, Yutskovskaya Y. Skin Quality - A Holistic 360° View: Consensus Results. Clin Cosmet Investig Dermatol. 2021 Jun 14;14:643-654. doi: 10.2147/CCID.S309374. PMID: 34163203; PMCID: PMC8214518.



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