We use a class 3B component laser in one of our products. It has a FDA accession number as a component and bears a big label stating
"Does not comply with 21CFR Ch1, 1040.10(f). For use in a Class 1 system only" So my advice is yes, FDA registration as a component is required. At the end of the day a Class 3B device is hazardous, and as an importer/manufacturere of a hazardous device, you need to show some due diligence and consideration to end use safety. [email protected] wrote: > 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] -- Andrew Carson - Product Safety Engineer Xyratex Engineering Laboratory Tele 023 92496855 Fax 023 92496014 ------------------------------------------- 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]
