If Mr. Gustavsson is involved I wonder why there&#x27;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&#x27;ll need data showing substantial equivalence to a predicate, unless they&#x27;ve come up with a way to get around the FDA. At a minimum they&#x27;ll have to register as a laser product with CDRH before they can ship anything. [2]<p>[1] <a href="http:&#x2F;&#x2F;pathsurveyor.com&#x2F;510k&#x2F;K013366" rel="nofollow">http:&#x2F;&#x2F;pathsurveyor.com&#x2F;510k&#x2F;K013366</a>
[2] <a href="http:&#x2F;&#x2F;www.fda.gov&#x2F;radiation-emittingproducts&#x2F;electronicproductradiationcontrolprogram&#x2F;gettingaproducttomarket&#x2F;default.htm" rel="nofollow">http:&#x2F;&#x2F;www.fda.gov&#x2F;radiation-emittingproducts&#x2F;electronicprod...</a>