FDA Approval (510K) Statement
At this time, most products that fit under the term "visible light", meaning frequencies between 400nm and 700nm, do not require FDA approval or acceptance. Obtaining a 510K Premarket Approval is an expensive and time consuming process that (in our opinion) doesn't really offer the customer any real assurances. Customers already know what the different frequencies do, be it 633nm, 660nm, 730nm or others. We build our systems to produce the exact same frequencies as these FDA approved models from manufacturers charging 400% more than we do, and at the same power levels.
We do not have plans at this time to submit for FDA approval as it seems superfluous given that a person can't be injured by the light itself, so there isn't any known safety considerations. Because of this, we can not and will not make medical claims. That doesn't mean our systems won't produce the same results as those other companies that DO make medical claims, just that we can't make the claims without the expensive FDA process being undertaken.
At the end of the day, what we produce creates the exact same frequencies, at the exact same power levels as the $40,000 - $60,000 systems. They just cost a lot less.
We do not have plans at this time to submit for FDA approval as it seems superfluous given that a person can't be injured by the light itself, so there isn't any known safety considerations. Because of this, we can not and will not make medical claims. That doesn't mean our systems won't produce the same results as those other companies that DO make medical claims, just that we can't make the claims without the expensive FDA process being undertaken.
At the end of the day, what we produce creates the exact same frequencies, at the exact same power levels as the $40,000 - $60,000 systems. They just cost a lot less.
