CLARTEIS

Clarteis specializes in ultraviolet phototherapy units designed for professional medical use. These devices are engineered to deliver controlled ultraviolet light exposure for therapeutic purposes, such as treating skin conditions. Examples include the Exciplex®, EXCI308 by Aerolase, and the Exciplex308nm, all of which fall under the category of professional ultraviolet phototherapy units.

Clarteis is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with US medical device standards.

Clarteis’s ultraviolet phototherapy units are classified as Class II medical devices under US regulations. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Yes, Clarteis’s devices are included in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that the devices are substantially equivalent to legally marketed predicates, while the UDI system ensures accurate identification and traceability of medical devices in the market.