Why does FDA clearance matter for UVB light therapy?

UVB light drives systemic health benefits, but can also cause sunburn and skin damage. The difference between a helpful dose and a harmful one can come down to seconds of exposure. That's why, in the United States, UVB devices intended to impact human health are regulated as medical devices and must be cleared by the FDA before they can be sold.

FDA clearance is not a formality. Before clearing Solius, the FDA reviewed its safety and performance testing, its light output, its labeling, and its risks against a specific intended use. Solius is the only personalized UVB light therapy device cleared by the FDA for over-the-counter use without a prescription (510(k) K252960).