ULTIMA UL-800 receives FDA 510(k) clearance
ULTIMA UL-800 receives FDA 510(k) clearance
We’re proud to share an important milestone for ULTIMA: the ULTIMA UL-800 has received FDA 510(k) clearance in the United States.
The clearance covers the ULTIMA System (UL-800), as well as the ULTIMA Face Package and Shape Extension Kits, under 510(k) number K260945.
For us, this is much more than another regulatory step. Entering the U.S. market has been an important goal for ULTIMA, and reaching this point has required extensive work across product development, technical documentation and regulatory compliance.
FDA 510(k) clearance confirms that the UL-800 has completed the FDA’s premarket review process for the cleared indications and provides the regulatory pathway for the device to be marketed in the United States.
The UL-800 was developed as a modular platform for professional muscle stimulation applications, allowing practitioners to work with different treatment areas and configurations within one system. The FDA clearance represents an important recognition of the work behind the technology and a significant step in ULTIMA’s international expansion.
We’re proud to see ULTIMA reach this point — and even more pleased to finally share the news.
ULTIMA Wins ‘Best for Lifting’ at the 2025 ELLE Tweakment Awards
We are proud to share that ULTIMA Face has been recognized at the inaugural ELLE Tweakment Awards 2025, taking home the title of Best for Lifting.
Curated by ELLE’s beauty editors, the awards highlight the very best aesthetic treatments and practitioners shaping the future of facial rejuvenation. This year’s guide offers clarity in a fast-growing and often unregulated market, spotlighting innovations that deliver real, visible results.
ULTIMA stood out for its unique approach to non-invasive facial lifting. By combining electro-muscle stimulation with high-intensity light therapy, the treatment provides an instant lifting effect — all without needles or downtime.
ELLE recommended the treatment at the Dr Maryam Zamani Clinic in London, but ULTIMA’s recognition extends far beyond a single clinic: it represents the international demand for safe, effective, and science-backed aesthetic solutions.