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Re: frenchbroad post# 399082

Monday, 08/28/2023 9:54:41 AM

Monday, August 28, 2023 9:54:41 AM

Post# of 403752

"I trust the principals who have actual experience to submit and receive successful USA FDA approval for laser surgery systems.
You do not and never will."



That's true, I have never submitted for FDA approval for laser surgery systems.

But I do have experience of steering four different medical devices through both the Premarket Notification 510(k) and Premarket Approval (PMA) FDA pathways.

Bsed on the claim that the principal makes about the time scale involved for what he claims is a revolutionary device and unique technology, I can assure you your trust in him is misplaced.

You're welcome.
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