At this time, our lenses do not have FDA approval. There are certain products that need FDA approval and some that do not. As it pertains to our lenses, and many of the other lenses on the market, we are not obligated to obtain FDA approval for various reasons. The main reason being that we are using materials and processes that have already been proven to be safe by the FDA. Other companies have previously submitted the materials and had them tested by the FDA, which allows for companies to use the same materials in manufacturing without the need for FDA approval.
In short, a company already paved the road, so it is not necessary for the companies that come after to pave another road on top of that.