UV lighting is not a cure for diseases already transmitted to humans and is not intended to be used for disinfecting people or equipment to be used in medical procedures on people. Instead, it is meant to sanitize the environments (air and surfaces) that people inhabit or come into contact with to prevent the risk of infection between people. As a result, Krypton and Lexus UV lights are not medical devices and thus do not require FDA approval. Far UV Technologies is regulated and registered with the EPA under Establishment #96253-MO-1.  Far UV Technologies complies with all FIFRA labeling and other regulatory requirements.