The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration has
implemented regulations for laser products manufactured since August 1, 1976. Compliance is
mandatory for products marketed in the United States. The device is certified as a “Class 1” laser product
under the U.S. Department of Health and Human Services (DHHS) Radiation Performance Standard
according to the Radiation Control for Health and Safety Act of 1968. Since radiation emitted inside the
device is completely confined within protective housings and external covers, the laser beam cannot
escape during any phase of normal user operation.
Using controls, making adjustments, or performing procedures other than those specified
in this user guide may result in exposure to hazardous radiation.