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.