Some times it can be as simple as proper labels, proving beyond a doubt that the lasers shut off when unblanked, or at least perform to the same level of failure statistics as the mechanical shutter, having the interlock supported in the cable, and using tamperproof screws in place of interlocks. You might also find out that X-Laser requires a certain amount of information about the install and facility for each unit, and adds that to a cumulative report.
IEC is a LOT less stringent in some areas then 21 CFR 1040. The fact that X-Laser is near DC might have helped a bit.
ILDA just asked CDRH to relax some rules. CDRH and ILDA have started a dialog about the "hypocracy" inherent in the fact that chinese imports do not get stopped by customs. CDRH called a meeting and ILDA went. That is progress.
X-Laser really doesn't get any special treatment, they just did their homework.
There is a ombudsman process some place for small businesses within FDA, you CAN call your regional EOS or others and ask for help.
Steve
Qui habet Christos, habet Vitam!
I should have rented the space under my name for advertising.
When I still could have...