Adding an ‘amen’ to Regan’s response. In most cases incorporating a laser product results in a new laser product that usually must be reported initially and annually. In situations of “bundling” such as including a barcode scanner product with a computer, might not result in a new laser product. But incorporating a laser sensor into industrial machinery usually does result in a new laser product.
Also keep in mind that any replacement parts put in commerce might need to be “registered”. The US Federal laser regulations were recently amended to incorporate some of the concepts in a few Laser Notices (perhaps LN 54). I certainly recommend reading the reg’s directly to understand obligations. Best Regards, -Lauren Confidential – Limited Access and Use From: Regan Arndt <[email protected]> Sent: Tuesday, June 18, 2024 5:14 PM To: [email protected] Subject: Re: [PSES] Fwd: Re: [PSES] Lasers You don't often get email from [email protected]<mailto:[email protected]>. Learn why this is important<https://aka.ms/LearnAboutSenderIdentification> External Email: Do NOT reply, click on links, or open attachments unless you recognize the sender and know the content is safe. If you believe this email may be unsafe, please click on the “Report Phishing” button on the top right of Outlook. Hello all, The manufacturer of the end-use product must ALSO submit an application to the CDRH (as a LASER PRODUCT) when they are incorporating an existing OEM laser or laser system that has a CDRH accession # associated with it. This manufacturer will then get a different accession # on this new submittal & must also do an annual report submission. You can obtain a guidance document directly from the CDRH at: https://www.fda.gov/radiation-emitting-products/home-business-and-entertainment-products/laser-products-and-instruments One of the definitions that are basic to the regulations are: A LASER PRODUCT is any device that constitutes, incorporates, or is intended to incorporate a laser or laser system [CFR 1040.10 (b) (21)] The accession # that is given to the manufacturer of the LASER PRODUCT system is merely just a tracking # (not a CDRH approval) for the end product model it is being sold into the USA. Hope that helps. Regan Arndt On Tue, Jun 18, 2024 at 2:47 PM Jim Bacher, WB8VSU <[email protected]<mailto:[email protected]>> wrote: Steve, both. The client has to file a yearly report as well. The client just refers to the OEMs FDA Accession number along with detailing labeling, manuals, etc. Jim Bacher, WB8VSU [email protected]<mailto:j.bacher%40ieee.org> or [email protected]<mailto:[email protected]> JBRC Consulting LLC Product EMC & Regulatory Consultant https://trc.guru/ email:[email protected]<mailto:jim%40trc.guru> IEEE Life Senior Member On June 18, 2024 5:39:08 PM sgbrody <[email protected]<mailto:[email protected]>> wrote: I have a client with a product that has a 3rd party Class 3B laser embedded. Who needs an FDA Accession number - laser manufacturer or my client as an end product containing an embedded laser? Thanks, ________________________________ This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. 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