- 2 -
DANGER
MAX RADIANT POWER <3mW
WAVELENGTH 660nm
LASER RADIATION
DO NOT STARE INTO BEAM OR
VIEW WITH OPTICAL INSTRUMENTS
CLASS IIIa LASER PRODUCT
E.
Labels and Warnings
Center for Devices and Radiological Health (CDRH) –
The United States Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is
the agency responsible for enforcing federal regulations regarding radiation-emitting devices in the U.S.
Because laser light is a form of radiation, it is monitored by CDRH, and we at Ultra Tec Manufacturing,
Inc. have an obligation to the government, to ourselves and most importantly, to our customers to ensure
that our products adhere to these regulations. Protecting consumers and complying with federal guidelines
are our top priorities.
The code of the Federal Regulations (CFR) is the set of government guidelines set forth by CDRH that
manufacturers of various products must follow. Specifically, guidelines 21 CFR 1040.10 and 1040.11
detail the standards that all laser products must meet. To comply with Federal regulations, all laser system
manufacturers must ensure that their products contain mandated safety features, register their products with
CDRH, and properly label each device with its respective warning data.
Laser products are regulated by CDRH based on the level of radiation emitted at a particular wavelength.
They are grouped into specific classes according to their maximum emission level.
Per requirements of various federal and multinational regulatory agencies all labels and warnings displayed
on or in the ASAP-1 are documented herein.
Certification and Identification:
Located on the rear panel
Class IIIa Laser:
Located on the face of the Ultracollimator LCD box just
below the Beam On/Off switch.
MODEL: Ultrapol Advance
SERIAL: 39945
LOCATION/DATE OF MFG:
Santa Ana, CA
October 2008
__________________________
CERTIFICATION:
This product
complies with 21 CFR 1040.10
AND 1040.11
___________________
Ultra Tec Mfg., Inc.
1025 E. Chestnut Ave.
Santa Ana, CA 92701
