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Re: cantwate post# 402112

Friday, 03/22/2024 5:16:51 PM

Friday, March 22, 2024 5:16:51 PM

Post# of 402700

"Sunspotter apparently BeaMed's laser is NOT a me too product as you want people to believe."



By definition filing for medical device approval via a 510(k) relies on your product being basically a literal copy of an existing product on the market (a "predicate").

So you can believe that fountain of truth and light, Leo "the disappearing CEO" Ehrlich in one of his last public pronouncements before he vanished from public view, or you can believe the FDA:

https://www.fda.gov/medical-devices/premarket-notification-510k/how-find-and-effectively-use-predicate-devices

Not a tough choice really.
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