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by akehrer 3904 days ago
If Mr. Gustavsson is involved I wonder why there's no mention of the regulations they need to pass before they can sell units in the US. I did a quick search [1] and found a few of the systems he has been involved in and they are all FDA Class II devices which is a long, involved process. They'll need data showing substantial equivalence to a predicate, unless they've come up with a way to get around the FDA. At a minimum they'll have to register as a laser product with CDRH before they can ship anything. [2]

[1] http://pathsurveyor.com/510k/K013366 [2] http://www.fda.gov/radiation-emittingproducts/electronicprod...

1 comments

Perhaps that is why they are going through Kickstarter... to get at the "dumb money" -- meaning that they want investment from people who arent going to ask about imperial entanglements regarding class II devices...

They want to get the thing made and out the door before scrutiny from FDA types would cost them more money than the actual product dev.