Xenex Disinfection Services, Inc.

Xenex Disinfection Services, Inc. specializes in ultraviolet microbial reduction units. These devices use ultraviolet light to reduce microbial contamination on surfaces and in the air, primarily designed for use in healthcare environments like hospital rooms and facilities. The company’s main product line, the LightStrike+, includes variations such as the MXSUV1-SL and MXSUV1-FT, which are tailored for different room sizes and configurations.

The company is based in the United States. This location is relevant for regulatory compliance, as its devices are authorised through the FDA’s processes, including 510(k) premarket notifications and the Unique Device Identifier (UDI) system.

Xenex’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations, confirming the devices meet applicable requirements for market authorisation.

Xenex’s ultraviolet microbial reduction units fall under Class II classification by the FDA. This classification is determined based on the device’s intended use and risk level, requiring special controls beyond general controls to ensure safety and effectiveness. Class II devices typically undergo 510(k) premarket notifications to demonstrate compliance with these controls.