Hi everyone,

 

I having trouble understanding the requirements for use of a Class IIIa laser
(laser pointer) for alignment purposes into a product line. Would I be
required to file an annual report to the CDRH. Now my research tells me that
if I conform to IEC60825-1 (self approving) or 1040.11 it would be compliant.
Does anyone have experience with this or can they please direct me to the
appropriate documents. I have searched the CDRH site and every thing leads to
I can use IEC60950 or 1040.11and12 but nowhere (that I can see) does it tell
me it is required. I have emailed the contact at the FDA listed in Laser
Notice 53 unsuccessfully. Any help would be appreciated.

 

Thank you.

Mark

 


Mark Schmidt
mschm...@xrite.com <mailto:mschm...@xrite.com> 



 

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