21 CFR 1040.1 and several CDRH memos and published guidance for manufacturers statements cover demonstration lasers and handheld. lasers. CDRH is part of FDA and FDAs enforcement strategy for any non-emergency violation is a long, drawn out, process.
FDA relies on US Customs to catch the illegal imports. Customs has other priorities and there is no such thing as a laser sniffing dog.
The process is complaint driven. It takes an actual incident or serious complaint to get the very small enforcement division of a very small FDA sub-branch to move. Getting a DA involved in on what is especially, essentially, a violation of civil law is tough. FDA policy is not to destroy small business but to aide it if possible by correcting violations in a "good intent" based methodology.
Getting "Red Listed" at Customs was not enough to put a crunch in their business.
While we're at it, Some Fan Fiction.:
A long time ago, Far Far away, in the light of the Redth Star, immune from Rebel Law,
A certain marketing team tied one of their product releases to a certain massive marketing franchise without permission. They slso styled their product to look like a certain fictional interplanetary faith based group's handheld "erbas" thingie. That Empire probably struck back with all sorts of private investigation and a force of lawyers, besides their PR team's bleatings. They uncovered US based assets that a lone investigator at a tiny division of a Rebel team did not have the resources to find.
That massive Empire's attorneys were more then willing to write memoranda detailing what intelligence they found and sent it
via courier to an overwhelmed Rebel Alliance office in the Maryland moonscape, , no doubt also CCing it to a certain Rebel Alliance General Counsel in the Columbia District. The Rebels could not believe their luck, as their laws had no force in the land of the Redth Star, but now they had a secret asset vent to whack.
That Rebel Alliance founded just before 1776 wrote a warning letter, waited for a reply, something or nothing happened, and A Rebel District Attorney finally decided it was worth their time to get involved, guided by the images provided by the civillian empire's political lobbying force and the rebel team
That Empire, fearing that their name might be tied to an accident or incident, quietly struck back, I guess.
End Fan Fiction...
Steve