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United States
Laser Safety
To assist with the FDA filing requirements (refer to Regulatory Requirements), Metrologic has registered the
scan engine with the FDA as a component. Customers can contact CDRH at the following address:
Food and Drug Administration
Center for Devices and Radiological Health
Light Products Branch (HFX-312)
Office of Compliance
2098 Gaither Road
Rockville, MD 20850
Tel: 301-594-4654
www.fda.gov/cdrh
Requirements for laser products are described in CFR (Code of Federal Regulation) Title 21, part 1040.10 &
1040.11 from the Government Printing Office. Copies can be ordered by calling 202-512-1800, ordering on
line from www.access.gpo.gov or writing to:
Superintendent of Documents
PO Box 371954
Pittsburgh, PA 15250-7954
Note:
State and local governments may regulate the use products containing lasers. The manufacturer
should consult the applicable government regulations for more information.
Copies of Product Reporting Guides, other guides, and related documents are available as PDF documents
from the CDRH website at:
www.fda.gov/cdrh/comp/eprc.html
. Additional resources include the Division of
Small Manufacturers, International and Consumer Assistance (DSMICA) in Rockville, Maryland at
1-800-638-2041.
EMC
Certain combinations of scan engines and associated electronics may require testing to insure compliance with
the following Federal Communications Commission regulation: 47 CFR Part 15
Note:
When using the scan engine with RF equipment, modems, etc. may require examination(s) to the
standard(s) for the specific equipment combination. It is the manufacturers’ responsibility to comply
with the applicable federal regulation(s).
The IS4800 series laser scan engine is designed to meet EN55022 Radiated Class B emission limits.
The engine was installed in a representative system and tested for compliance.
