Informational US FDA Laser guidances

EAI

Registered
Hi Marcelo,
My company is developing a medical device (class I). We use a laser (2M) that is certified by its manufacturer (IEC 60825), it comes with the corresponding label.
When assembling our device this label obviously is not visible. My question is ... Do we have to re-label? that is, add the laser tag in a visible place on my device?
Thanks!
 

Marcelo

Inactive Registered Visitor
It's been years since I worked with the laser standards, but either IEC 60825 or IEC 60601-2-22 should have specific requirements for that specific label.
 
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