Laser pointers fall under Surveying, Leveling, and Alignment (SLA) laser products per the U.S. FDA’s Center for Devices and Radiological Health’s (CDRH) regulations in 21CFR Part 1040.11(b).  The CDRH laser class limit for SLA laser products, including laser pointers, is Class IIIa. The CDRH also accepts IEC 60825-1 Class 3R as equivalent to CDRH Class IIIa. Both of these CDRH and IEC 60825-1 laser classes would equate to a laser power that does not exceed 5mW.  Laser powers over 5mW can be hazardous, causing potential issues such as temporary visual problems or eye injuries.  Therefore, any laser pointer emitting radiation over Class IIIa/3R are not allowed to be imported into, sold or promoted in the United States.

Due to the variety of applications, the stated CDRH restrictions, and vast list of potential users (anyone from children to business professionals) of laser pointers, there is a growing need to have a 3rd party confirm a laser pointer manufacturer’s CDRH self-certification. This need is further boosted by recent NIST findings that show inaccuracies in the stated laser powers/classifications on sample laser pointers tested. The NIST findings indicated that nearly 90% of green pointers and approximately 44% of red pointers were not in compliance with federal safety regulations.

To help manufacturers support and confirm their CDRH self-certification for laser pointers, UL has full service laser testing laboratories in the United States, Japan and Korea where all types of laser products are tested to both CDRH and IEC laser safety requirements. UL can provide services that range from laser pointer safety testing to a full laser testing service resulting in a complete CDRH Report ready to file with the FDA or an IEC 60825-1 CB Test Report with CB Certificate.

The laser pointer safety testing report could also be used by retailers who sell laser pointers (manufactured by other companies), to demonstrate they are selling a product that meets the U.S. CDRH or other global requirements for laser safety.

In addition to the above services, UL Certification of laser pointers is possible, which would enable the laser pointers to bear the UL Mark after successful completion of the required product evaluation.

 

Related Links:

FDA Requirements for Laser Product Safety

IEC Requirements for Laser Product Safety

Laser Product Safety FAQs