BellaMia Technologies, Inc. has secured 510(k) clearance from the U.S. Food and Drug Administration for The Botticelli™, its integrated laser platform for skin rejuvenation, according to the company.
The Botticelli combines multiple laser wavelengths and includes all necessary components to treat a broad range of skin conditions in a single device. The company claims this marks the first multi-wavelength, all-in-one system cleared specifically for comprehensive facial rejuvenation.
According to BellaMia, the device aims to consolidate what would traditionally require several separate tools into one compact platform. The company says this could reduce treatment time and simplify workflows in plastic surgical practices.
The FDA’s 510(k) clearance confirms that The Botticelli is substantially equivalent to legally marketed devices, allowing BellaMia to market it in the U.S. The company highlights this milestone as a transformative step in aesthetic device innovation.
BellaMia Technologies, headquartered in San Antonio with operations and manufacturing in Orlando, develops aesthetic devices it describes as first-in-class.
