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Laser legalities

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marty

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Jun 21, 2009, 1:25:12 PM6/21/09
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I would like to import and sell a 650nm 5mw laser diode modules. Can
anyone direct me as to any FDA restrictions, regulations ect including
any import restrictions etc. The laser has a focusable lens and
actually the specs are less than 5mw and the wavelength is actually
more like 657.

Any help anyone can give me would be greatly appreciated.

o...@uakron.edu

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Jun 21, 2009, 9:27:10 PM6/21/09
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Call CDRH and ask for DANIEL J. HEWETT

If it already has a accession number, its just paperwork. If no
accession number, you need to file a manufacturers report, import
paperwork, quality control and recordkeeping.

What does the laser do?

Steve

o...@uakron.edu

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Jun 21, 2009, 9:28:40 PM6/21/09
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21 CFR 1040.1
is the start of the regs.

CDRH sends out a paperwork package with guidance to help you start, I
believe it is now available as a PDF>

Steve

marty

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Jun 21, 2009, 11:06:45 PM6/21/09
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Steve Thank you so much for your help! Is there a phone number for
this Daniel J. Hewett?

James Sweet

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Jun 21, 2009, 11:30:31 PM6/21/09
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Import to and from where? The description sounds pretty much like the
ubiquitous laser pointers that are everywhere, though modules are
usually significantly higher quality.

marty

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Jun 22, 2009, 1:02:04 AM6/22/09
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Import from China and sell in the U.S. The problem is I will be
selling these very cheap and if I'm doing anything wrong I'm sure
competitors will shut me down.

marty

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Jun 22, 2009, 8:35:49 PM6/22/09
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Steve. never mind. I found Daniel J. Hewett and e-mailed him. Many
thanks for your help!

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