Merz Aesthetics
Ultherapy PRIME®
microfocused ultrasound with visualization (MFU-V) skin-lifting device
Ultherapy PRIME is made by Merz Aesthetics and is the current generation of Ultherapy, a non-surgical treatment that uses focused sound waves (ultrasound), rather than a laser or a needle, to gently warm a layer of tissue beneath the surface of the skin; Merz states that controlled warmth is intended to stimulate the body's own production of collagen over time. What sets this device apart from many other ultrasound-based machines is that the provider can see an image of the layers beneath the skin on a screen while treating, so the energy can be aimed at a specific depth rather than applied blind; Merz describes that pairing of real-time visualization with non-invasive ultrasound lifting as what sets the device apart from other ultrasound systems. Ultherapy originally received FDA clearance (via the De Novo pathway) for a non-invasive brow lift in September 2009, followed by clearance for the neck and under-chin area in 2012, for ultrasound visualization of tissue layers in 2013, and for improving lines and wrinkles on the décolleté (upper chest) in 2014. Merz Aesthetics launched the newer "Ultherapy PRIME" platform on September 23, 2024, describing it as delivering a clearer real-time image on screen and a faster treatment session compared with the earlier-generation system; Merz has since announced additional FDA clearances extending Ultherapy PRIME to skin laxity on the arms and abdomen (November 5, 2025) and, most recently, the knees (August 11, 2026). Merz describes results as developing gradually over the weeks following treatment as the body's own collagen response continues, rather than appearing immediately.
The record
- Ultherapy's original FDA clearance, for a non-invasive brow lift, was granted via the De Novo 510(k) pathway in September 2009 (BioSpace/Ulthera press coverage; exact day cited as September 16 in one source)
- FDA clearance for non-invasive neck and submental (under-chin) lift followed in October 2012
- FDA clearance for ultrasound visualization of dermal and subdermal tissue layers followed in 2013, and for improving lines and wrinkles on the décolleté in 2014
- Merz Aesthetics launched the Ultherapy PRIME platform on September 23, 2024 (Merz Aesthetics press release)
- Merz Aesthetics announced FDA clearance of Ultherapy PRIME for skin laxity on the anterior arms, posterior arms, and abdomen on November 5, 2025 (Merz Aesthetics; Businesswire)
- Merz Aesthetics announced FDA clearance of Ultherapy PRIME for skin laxity on the knees on August 11, 2026 (Businesswire, syndicated via multiple trade outlets)
- Merz describes the PRIME platform's on-screen visualization as 72% clearer and treatment as roughly 20% faster than the prior-generation Ultherapy system (Merz Aesthetics)
Where this came from
- Innovating Aesthetics: The Legacy of Ultherapy - Ultherapy (Merz Aesthetics)
- Merz Aesthetics Announces the Launch of Ultherapy PRIME Platform as the Next Generation of Nonsurgical Skin Lifting Treatments - Merz Aesthetics
- Merz Aesthetics Announces New Arms and Abdomen Indication for Ultherapy PRIME, the Only FDA-Cleared Ultrasound With Real-Time Visualization - Merz Aesthetics
- Ulthera Receives First-Ever FDA Clearance to Market Ultrasound Technology for Facial Aesthetic Improvement - BioSpace
Also in lasers and light
Ultherapy PRIME® and its logo belong to Merz Aesthetics. This page describes equipment and products used at UDERMA Medspa & Laser; it is general information, not medical advice, and whether this one suits you is a conversation to have at a consultation.
Want to know if this is right for you?
UDERMA Medspa & Laser · 36426 US Hwy 19 N, Palm Harbor, FL · 727-569-6616
Book a consultation