In order for medical devices, drugs and biologics to be legally marketed and sold in the United States, they are required to be either cleared or approved by the FDA unless the product and intended use is 510(k) exempt. This isa regulatory process to ensure that the product is safe and efficacious in its use.FDA-Approval is required for high risk Class 3 drugs and biologics. Our LED technology in our Light boost range of products is Class 2, which is a much lower risk, and its route tomarket is via either a 510K, or de novo submissionfor FDA-Clearance or the technology is 510k exempt.We pride ourselves on not only acquiring the correct regulations for our products, but also accurately marketing them to our consumer