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.