If I follow this pr right, it means we will have, upon acknowledged receipt by the patent office, 4 additional patents pending. They will be on tool designs provided by ViR.
Any additional tools beyond the two in FDA review as we currently have been told, such as these new designs, will need to go thru the 2-6 week average FDA review, via 510k most likely. The 2-6 weeks being the time frame Ninja and I estimate for 510ks on tools/wands, taken from the FDA website.
This time frame was dependant on the genset and previous tools having been approved.
From what I've seen, the SE comparison for the new tools then is stated as comparable to one of the previous tools we will have already approved and one of the comparables from the original 510k on the original genset and tool submission.
We at present, do not know if we have a final beta version
of additional tools beyond the 1st 2 now in FDA review.
But the pr leads me to believe the designs for more tools are ready and waiting. Once the current 510ks under review are approved, then the co. may be able to start production on all products but the new tools, currently sitting on the draft board, will not be distributed till FDA submission and approval in the U. S. for sure.
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