STATEMENT ABOUT UVC LIGHTFORCE’S RELATIONSHIP TO FDA:
JANUARY 3, 2021
On June 13, 2018, UVC Lightforce submitted a 513(g) request to FDA for the purpose of determining if our products were classified as medical devices. On December 20, 2018, the Company received a response stating that [under Section 201(h) of the Federal Food Drug and Cosmetic Act,] its products are NOT medical devices. Accordingly, none of UVC Lightforce products are certified, or approved under any applicable laws, as a medical device. UVC Lightforce, and its Representatives and Distributors, do not currently intend for them to be used as medical devices.
Last Modified: July 14, 2020
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