From FDA laser compliance guide:
Laser products are classified on the basis of the highest level of laser
radiation to which human access [1040.10(b)15)] is possible
during operation
only
. Other laser radiation fields to which human access is necessary
only
during maintenance or service
do not affect the classification but may affect
the labeling and safety interlock requirements. Use-factor data, if available
and adequately convincing, may be used in determining the level of laser
emissions from a product.