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SE 2223/3223 Scan Engine Integration Guide
United States
Food and Drug Administration, Center For Devices and
Radiological Health (CDRH)
U.S. Federal Laser Product Performance Standard
Laser products fall into two major categories, components and finished products. The scan
engine is a component. When placed in a properly labeled housing it becomes a laser
product.
The FDA requires a laser product report to be on file with the FDA prior to introducing the
product into commerce. The person (i.e., a one-person operation) or company who places
the scan engine into a housing is the “manufacturer” of this laser product. This
“manufacturer” establishes the specifications for the finished product and is responsible for
compliance with Federal CDRH laser product requirements. These Federal regulations
include:
21 CFR Subchapter J - Radiological Health:
Part 1000 - General
Part 1002 - Records And Reports
Part 1003 - Notification Of Defects Or Failure To Comply
Part 1004 - Repurchase, Repairs, Or Replacement Of Electronic Products
Part 1005 - Importation Of Electronic Products
Part 1010 - Performance Standards For Electronic Products: General
Part 1040 - Performance Standards For Light-Emitting Products
Under the requirements of Part 1040 the manufacturer is required to classify the laser
product, and then certify through the Laser Product Report that all requirements
(performance features) of the standard have been complied with.
To support the customer with the FDA filing requirements, the scan engine has been
registered with the FDA as a component under the following model number scheme:
SE-3XXXXXX-XXXXX, SE-2XXXXXX-XXXXX. Customers are encouraged to refer to this