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 | | From: | Chris Carlen | | Subject: | What is a legal laser? | | Date: | Thu, 06 Jan 2005 11:35:11 -0800 |
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 | Greetings:
I spent some time at the CDRH site the other day trying to figure out
what the legal requirements are for legally obtaining, selling, and
manufacturing laser products, and also as it pertains to importing a
laser from an overseas vendor.
As I have understood in the past, there are "OEM" or "laser devices" or
"laser components" that don't have to be keylocked, shuttered, emission
indicator, etc. to be legally entered into commerce. Because of this,
surplus dealers, and hobbyists selling their lasers to fellow hobbyists,
seem to be able to slide through unscathed.
According to 21CFR1040.10, it seems to say that the more stringent rules
for labeling, performance features, certification, and lengthy reporting
and registering with the CDRH DO NOT APPLY for lasers that are sold as
components. (See quoted beginning section of 21CFR1040.10 below)
However, the wording and applicability still seems vague to me. The
question for sellers and hobbyists and/or others who want to obtain and
utilize a laser component, is that if we intend to USE the component
rather than manufacture a product which will then be made compliant with
CDRH rules, is this allowable?
1. For instance, if the hobbyist or academic researcher purchases a
non-compliant HeNe laser (no key switch, shutter, emission indicator,
certification, registration, etc) from a surplus dealer, and USES the
laser in the lab rather than manufactures a product with it (which then
goes through all the certification hoops), then is it legal for the
seller, and is it legal for the buyer?
2. The same question can be applied to an actual manufacturer of laser
devices, if they sell in the context of an "OEM" component, but the
purchaser USES the laser rather than manufactures a product from it?
Do the rules pertain to only manufacturers, or also to second-hand
sellers, and users?
In other words is it only illegal to sell a non-compliant laser
(non-compliant with 1040.11 because it is considered an OEM) or is it
also illegal to OWN and USE it?
Puzzled.
Notice also the part that reads: "(iii) Is not a removable laser system
as described in paragraph (c)(2) of this section; and..."
Most of the OEM stuff that hobbyists and laser users on the cheap
purchase likely qualify as removable laser systems (section also quoted
below).
I can't believe I have spent so many hours this week trying to
understand the rules, instead of doing my work.
We are going to drive our economy into the ground with regulations. I
for one am willing to register with the official list of those who have
given up any consideration of attempting to become a technological (or
other) entrepreneur based on my own funding and ingenuity, due to the
weight of regulations, fear of getting into trouble, and the fact that
if I hire legal professionals to deal with these matters for me, the
costs to my business activity will render it unprofitable. So whatever
economic benefits could have been realized from my skills and
willingness alone, won't be.
Good day!
Quoted from:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=1040.10
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Sec. 1040.10 Laser products.
(a) Applicability. The provisions of this section and § 1040.11, as
amended, are applicable as specified to all laser products manufactured
or assembled after August 1, 1976, except when:
(1) Such a laser product is either sold to a manufacturer of an
electronic product for use as a component (or replacement) in such
electronic product, or
(2) Sold by or for a manufacturer of an electronic product for use as a
component (or replacement) in such electronic product, provided that
such laser product:
(i) Is accompanied by a general warning notice that adequate
instructions for the safe installation of the laser product are provided
in servicing information available from the complete laser product
manufacturer under paragraph (h)(2)(ii) of this section, and should be
followed,
(ii) Is labeled with a statement that it is designated for use solely as
a component of such electronic product and therefore does not comply
with the appropriate requirements of this section and § 1040.11 for
complete laser products, and
(iii) Is not a removable laser system as described in paragraph (c)(2)
of this section; and
(3) The manufacturer of such a laser product, if manufactured after
August 20, 1986:
(i) Registers, and provides a listing by type of such laser products
manufactured that includes the product name, model number and laser
medium or emitted wavelength(s), and the name and address of the
manufacturer. The manufacturer must submit the registration and listing
to the Director, Office of Compliance (HFZ-300), Center for Devices and
Radiological Health, 2094 Gaither Rd., Rockville, MD 20850.
(ii) Maintains and allows access to any sales, shipping, or distribution
records that identify the purchaser of such a laser product by name and
address, the product by type, the number of units sold, and the date of
sale (shipment). These records shall be maintained and made available as
specified in § 1002.31.
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(2) Removable laser systems. Any laser system that is incorporated into
a laser product subject to the requirements of this section and that is
capable, without modification, of producing laser radiation when removed
from such laser product, shall itself be considered a laser product and
shall be separately subject to the applicable requirements in this
subchapter for laser products of its class. It shall be classified on
the basis of accessible emission of laser radiation when so removed.
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_______________________________________________________________________
Christopher R. Carlen
Principal Laser/Optical Technologist
Sandia National Laboratories CA USA
crcarle@sandia.gov -- NOTE: Remove "BOGUS" from email address to reply.
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