Medical laser products are products that are medical devices manufactured, designed, intended, or promoted for in vivo irradiation of the human body for diagnosis, surgery, therapy, cosmetic interventions, or for determining the relative position of the human body.
Class Ilia, Illb, and IV medical laser products must contain a means for measuring the delivered exposure or treatment level of radiation, accurate within 20%. This requirement is not applicable to Class IIIa aiming devices, except to ophthalmic application. The instruction manual must include a procedure and schedule for recalibration of the measurement system. A modified aperture label is also specified.136