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Xenex Makes De Novo Petition to FDA for LightStrike UV Room Disinfection Technology

Xenex Disinfection Services filed a De Novo petition with the U.S. Food and Drug Administration (“FDA”) for medical device market authorization of its LightStrike+ ultraviolet (UV) room disinfection technology. The company’s patented device uses a xenon lamp to create broad spectrum UV light intended to quickly destroy pathogens on surfaces in healthcare facilities.  Xenex‘s LightStrike technology is currently being sold pursuant to an FDA enforcement policy that was issued to allow light based disinfection products to be brought to market during the global pandemic (Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency).  The De…
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