FDA De Novo Clearance Given LightStrike+ UV Broad Spectrum Disinfection Robot

Creating a new medical device classification, the FDA has granted Xenex Disinfection Services’ LightStrike+ high-intensity, broad-spectrum ultraviolet (UV) light robot a De Novo marketing authorization.

The LightStrike+ robot is designed, the company said, “to perform microbial reduction on noncritical medical device surfaces free from visual soiling in the healthcare environment following manual cleaning and disinfection practices.”

The robot has a run time as short as two minutes and uses “high-intensity pulsed UV light that reduces the number of those pathogens on surfaces and helps to break the chain of transmission from one patient or healthcare worker to the next,” according to Xenex.

The San Antonio, Tex., based company says the robots are currently available.

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