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by akehrer
3904 days ago
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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... |
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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.