Rich,

Here's some info for you . . . 

http://www.fda.gov/ohrms/dockets/98fr/032499d.txt

Read "I - Background". The second paragraph answers the question in more
detail
than my previous post.

John A. Juhasz
Product Qualification &
Compliance Engr.

Fiber Options, Inc.
Bohemia, NY 11716 USA

 

-----Original Message-----
From: [email protected] [mailto:[email protected]]
Sent: Friday, November 19, 1999 10:25 AM
To: [email protected]
Subject: FDA and LEDs



Am I correct in understanding that the FDA regulations (21 CFR Part 1040) do
not consider LEDs to be Lasers? A Laser is defined by the FDA to be a device
that has emissions of certain wavelengths "primarily by the process of
controlled stimulated emission." I understand that an LED does not use this
process.

I also understand that the FDA, following the lead of IEC825, once
considered creating performance standards for LEDs but failed to do so. Is
that correct?

Richard Woods

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