ProLaser III Operator's Manual
Page 36
REGULATORY COMPLIANCE
Manufacture and operation of the ProLaser III is
subject to the regulations of two governmental agencies,
the Center for Devices and Radiological Health (or CDRH),
and the Federal Communications Commission. The
following sections describe the requirements of these two
agencies, and the manner in which the ProLaser III
complies with their regulations.
EYE SAFETY
CDRH is an agency of the federal Food and Drug
Administration that has the responsibility of ensuring the
safety of all laser products sold in the US. The ProLaser
III is certified as a Class I device in accordance with the
safety standards of CDRH. Class I is the lowest
classification of laser product in terms of relative potential
risk. A good description of this category is provided by the
Laser Institute of America as follows:
Class I - A Class I laser is considered safe
based upon current medical knowledge. This
class includes all lasers or laser systems which
cannot emit levels of optical radiation above
the exposure limits for the eye, under any
exposure conditions inherent in the design of
the laser product. There may be a more
hazardous laser embedded in the enclosure of
the Class I product, but no harmful laser
radiation can escape the enclosure.
