Mr Jensen, FDA aplies to laser classification of complete products. It does not refer to a component. However, many laser manufacturers obtain an FDA Accession # and/or UL Recognition and/or TUV Approval since they do not wish to provide the laser compoent schematics and parts list to the end-product manufacturer for further evaluation. It is therefore recommended that the component also be provided with an FDA Report and agency approvals.
Best Regards -----Original Message----- From: [email protected] [mailto:[email protected]] Sent: Wednesday, January 10, 2001 9:58 AM To: [email protected] Subject: Laser approval Hi all, I have been asked if a laser which will be sold as a component will have to be FDA approved. IEC 825 does not include lasers which are components, only end-user products. I can't understand the FDA requirements concerning components. The laser is a Class 3B laser Please send me a clear simple answer, if anybody can. K. B. Jensen ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected] ------------------------------------------- This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. To cancel your subscription, send mail to: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Jim Bacher: [email protected] Michael Garretson: [email protected] For policy questions, send mail to: Richard Nute: [email protected]
