Devices

Xenex Files De Novo for Disinfection Device

Xenex Disinfection Services has filed a de novo petition for its LightStrike+ ultraviolet (UV) room disinfection technology. The company’s device uses a xenon lamp to create broad spectrum UV light intended to destroy pathogens on surfaces in healthcare facilities. It has been marketed during the Covid-19 emergency under FDA’s enforcement discretion (Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency), and the de novo submission is intended to transition the disinfection technology to a legally marketed device, according to the company. The submission includes “substantial data on testing with the device and leverages the robust scientific evidence published in peer-reviewed articles about the efficacy of the LightStrike disinfection technology,” it says.

Xenex Files De Novo for Disinfection Device

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