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
Sent: Tuesday, June 18, 2024 5:14 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: Re: [PSES] Fwd: Re: [PSES
-54>
to see if it applies to your client's device.
Best regards,
Ted Eckert
The opinions expressed are my own and do not necessarily reflect those of my
employer.
From: sgbrody
Sent: Tuesday, June 18, 2024 5:16 PM
To: EMC-PSTC@LISTSERV.IEEE.ORG
Subject: [EXTERNAL] [PSES] Lasers
You don&
Thanks to those who responded to my question.Sent from my T-Mobile 5G Device
-
This message is from the IEEE Product Safety Engineering Society emc-pstc
discussion list. To post a message to the list, send your e-mail to
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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
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
j.bac...@ieee.org or ja.bac...@outlook.com
JBRC Consulting LLC
Product EMC & Regulatory Consultant
https://trc.gu
Have you asked the laser maker? Surely they know fur certain.
On 2024-06-18 22:38, sgbrody 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?
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,Sent from my T-Mobile 5G Device
-
Hi Steve,
Generally speaking for Class 3 lasers that are conducted from the laser to a
receiver or point of use, the fibre should be interlocked with the laser safety
interlock so that that laser cannot operate if the fibre is disconnected. For a
Class 4 laser this is a mandatory requirement.
Laser Ecperts: if a 3B laser light is transmitted via fiber optic cable, is
there a requirement for any connections in that cable, if opened, trigger the
laser generator to shut down the laser?Cable is secured in place from end to
end, but it is possible for service personnel to unsecure the cab
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