All, I am not sure of the cost of your device or its intended market but I seem to remember an exemption for laser devices with a cost of less than $50. I can't find the clause at the moment, if I do I will let you know. I would start at the FDA's CDRH website http://www.fda.gov/cdrh/ the standards can be accessed from here.
Regards, Josh From: [email protected] [mailto:[email protected]]On Behalf Of John Jankowski Sent: Tuesday, April 06, 2004 11:09 AM To: AaA?E?; [email protected] Subject: RE: Laser pointer Michael, You will need to submit to CDRH, an initial product report for any laser product sold in the US. Unless the laser diode you mentioned is actually a self contained module that limits the output power to a given laser class, most solid state laser diodes themselves could be adjusted within any of several Laser Class limits. If you do utilize one of these "Pre-Classified" modules, it would be considered a component of your final product and that product would still require a report to CDRH showing compliance with the product labeling requirements, output levels, control system, etc. All said, you may not need any additional testing, however if you have limited experience in this area of compliance, you may want to seek assistance with the submittal of the report. There are several Laser safety consultants to be found by doing a Web search. It's been too many years since my days with IEC TC-76 to provide any names off the top of my head. Regards, John A. Jankowski From: 장창호 Sent: Tuesday, April 06, 2004 1:26 AM Hi everyone. I have a question. Does 'Laser Pointer' need verify for DHHS even if laser diode verified? If need, would you recommend test agency? This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ieee-pses.org/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ieee-pses.org/ To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
