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What Is FDA Approval?

FDA Approval is the process by which the Food and Drug Administration approves food drugs, medical devices and other products. In Vioguard’s case, the Food and Drug Administration approved the UV-C technology used in our products. It is a rigorous process and can take months or even years. The tech was taken through a series of tests to determine the accuracy at which it killed pathogens. It was determined to have a 99.99% kill rate. Click here to see the FDA approval document.

What Is FDA Clearance?

FDA clearance is the process by which the FDA clears a product under an already-approved technology. In Vioguard’s case, the approval of the technology was complete, and then we moved forward to get the original product model UVKB50 cleared. That meant the FDA determined the product was not only effective, but safe for users.

What Is This The Significance Of Approval And Clearance?

Vioguard’s technology is the only FDA approved ultraviolet solution for surface sanitation on the market. It went through some seriously rigorous testing to achieve approval. That evokes our customers’ confidence that whatever pathogens are being dosed by Vioguard’s UV-C light are killed. Not only that, but users can be confident they will not be exposed to harmful rays of UV-C light.

When Did Vioguard Become FDA Approved? Cleared?

The FDA approval process began in 2010. After approval was achieved, the original UV-C self-sanitizing product was cleared by the FDA at the end of 2011 just in time for its launch in 2012.

Contact Us

425.318.7900

19201 120th Ave NE, Ste 200
Bothell, WA 98011

[email protected]

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