• Ultherapy PRIME is now the only FDA-cleared solution with real-time visualization to treat the face, neck, décolleté and the body.¹  
• 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 to-date and a 95% satisfaction rate.^1-3
• As the skin-lifting market is expected to grow approximately 9% by 2030⁴, Ultherapy PRIME is meeting increasing consumer needs for noninvasive treatments that address skin laxity.  

November 5, 2025 — 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. With these new clearance areas, the nonsurgical skin tightening treatment becomes the only FDA-cleared solution with real-time visualization to treat the face, neck, décolleté and body.

How does Ultherapy work?

Ultherapy uses micro-focused ultrasound energy to target deep tissue layers and stimulate your body’s natural collagen production. It targets the same tissue planes as a face lift without the incisions.

Ultherapy is scientifically supported by more than 120 publications and over 3 million treatments in more than 80 countries worldwide. Ultrasound energy has been used in the field of medicine for more than 50 years.

What is Ultherapy PRIME?

It’s the only treatment cleared by the FDA for lifting the brow, skin on the neck and under the chin as well as improve lines and wrinkles on the décolleté and to improve the appearance of skin laxity on the abdomen, anterior arms, and posterior arms.

Ultherapy PRIME uses real-timing imaging to help practitioners visualize the area and personalize treatment with long-lasting results that can last up to a year or more. The ultrasound technology stimulates the formation of new collagen deep below the skin’s surface.

Compared to the legacy Ultherapy treatment, providers reported that Ultherapy PRIME delivers 20% faster treatment in one session.

What does an Ultherapy procedure look like?

Before receiving treatment, you will meet with a licensed practitioner for the initial consultation (also called a good faith exam). During the consultation, the specialist will assess your skin, talk about your aesthetic goals, and ask about your medical history to determine whether you are a good candidate for treatment with Ultherapy.  

Ultherapy is safe for all skin tones and can help patients with some skin laxity or loss of elasticity who are not ready for a surgical facelift. If Ultherapy is a good match, the practitioner will design a one-session treatment plan for your specific needs.

Read more about What to Look for in a Safe Med Spa Visit.

Steps of an Ultherapy treatment

It’s a noninvasive, 30–90-minute appointment. Length of the treatment will also depend on the size and number of FDA-cleared areas being treated.

Before treatment, providers may employ a numbing cream or prescribe painkiller to help the patient feel comfortable during the procedure. These will be built into individual treatment plans and may impact the length of treatment.  

After cleansing the treatment area, the provider will use a surgical skin marker to map out the treatment area. Then they will apply ultrasound gel and place a smooth treatment applicator against your skin. Ultherapy PRIME’s real-time imaging will help your provider visualize and assess your deep skin layers to precisely deliver ultrasound energy where it’s needed. Patients may feel heat or tingling where the ultrasound energy is delivered to the tissue.

This non-invasive treatment comes with zero downtime, so patients can resume normal activities, following the instructions of their practitioner. Patients may experience redness, swelling, pain and transient nerve effects, but these are typically mild and temporary.

Patients may see an initial lift after one session, with full effects in 2-6 months as collagen and elastic develop. Skin-lifting results can last up to a year or more.  

Who can provide Ultherapy in a med spa?

Ultherapy uses ultrasound energy to stimulate the formation of collagen deep below the skin’s surface. Because of this, it will be considered a medical treatment and need to be performed by or under the authority of a healthcare practitioner. What licensing or training is needed to perform this treatment will depend on the rules of the state in which you are located. But in general, a physician or an appropriately trained physician assistant (PA) or advanced practice registered nurse (APRN, such as a nurse practitioner (NP)) will likely be able to provide this treatment.  

For an easy reference on who can perform non-surgical skin tightening and 20 other aesthetic treatments, AmSpa Plus Members can refer to their treatment delegation table and answers to 100+ of the most pressing med spa law questions in their state legal summary. As always, you will want to check with your advisors and review your local rules before adding a new device or treatment to your practice.

To highlight the latest body indications, Merz Aesthetics is also launching a new global campaign for Ultherapy PRIME. The new indications will launch in the U.S. before expanding to markets worldwide. To learn more about Ultherapy PRIME or find an Ultherapy provider near you, visit Ultherapy.com.

Ultherapy®:  

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.  

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 Number 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.  

© 2025 Ulthera, Inc. All Rights Reserved. MERZ AESTHETICS® is a trademark and/or registered trademark of Merz Pharma GmbH & Co. KGaA in the U.S. and/or certain other countries. ULTHERA, ULTHERAPY, ULTHERAPY PRIME and ULTHERAPY PRIME THE LIFT YOU CAN SEE are trademarks and/or registered trademarks of Ulthera, Inc. in the U.S. and/or certain other countries.  

Various features of the ULTHERA® System are covered by U.S. patents identified at https://merzaesthetics.com/patents/. Other U.S. and international patents to which Ulthera, Inc. has rights are issued, published, or pending.  

For additional information, including important safety information, please visit Ultherapy.com.