Serious, you are absolutely correct. Thus, I stand corrected. So I take it that BIEL has not submitted a 513(g), nor a De Novo? If they have yet to make the aforementioned submittals, then we have at least additional months to wait before the FDA makes its decision.
Wait time for respective submissions: 513(g): within 60 days De Novo: within 120 days
The Time Machine Laser was just cleared for a 510K with a predicate (unknown) yet the product is marketed as "unique". so how can a unique product have a predicate?
in fact the similarities of the process may be close to the BIEL case - where we know there is a predicate device it just wasn't cleared for OTC which is a completely separate property of the application an argument we have been told that has been accepted. OTC is about safety and ability of public to self prescribe which have all been covered.
we will know within 3 weeks assuming yesterday's meeting is the final one.
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