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Old 01-11-2011, 06:58 PM #1
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Default What is required to legally sell a class 4 laser product

What is required to legally sell a class 4 laser product in the US specifically Texas. The Product is a Lab mountable source, not hand-held. I've read the ANSI standards and the device is in compliance. What else is needed? I assume I have to register with someone to get those laser warning tags that state the device is in compliance.

Any help or direction is appreciated.


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Old 01-11-2011, 07:24 PM #2
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Default Re: What is required to legally sell a class 4 laser product

register with FDA, dunno much because I live in brazil, but I read it somewhere else.
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Old 01-11-2011, 07:25 PM #3
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Default Re: What is required to legally sell a class 4 laser product

First you need to ensure that your product has all of the required safety features:

A shutter for the laser emission aperture.
An interlock which disables the laser before it is accessed. This can be a simple pressure switch on a cover panel.
A key lock on the power switch.
A 5 second delay between the time when you enable laser emission and actual emission begins.
A Laser emission indicator (LED or light bulb)
Proper labeling in accordance with FDA/CDRH rules.

Here's a link to a zip file which contains pretty much everything you need in terms of paperwork and links to the FDA/CDRH documents.

http://dl.dropbox.com/u/2843911/CDRH.zip

You must complete and submit a product report, which is a request for a variance for the products based on their construction and safety features. The FDA will review your product report and if everything checks out they will give you approval to enter your product into commerce. It is a LOOOOONG process waiting for the FDA/CDRH to act. Hiring lawyers can speed up the process, but as always they cost money.
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Last edited by ElektroFreak; 01-11-2011 at 08:33 PM. Reason: missed the key lock
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Old 01-11-2011, 07:26 PM #4
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Default Re: What is required to legally sell a class 4 laser product

Quote:
Originally Posted by ElektroFreak View Post
First you need to ensure that your product has all of the required safety features:

A shutter for the laser emission aperture.
An interlock which disables the laser before it is accessed. This can be a simple pressure switch on a cover panel.
A 5 second delay between the time when you enable laser emission and actual emission begins.
A Laser emission indicator (LED or light bulb)
Proper labeling in accordance with FDA/CDRH rules.

Here's a link to a zip file which contains pretty much everything you need in terms of paperwork and links to the FDA/CDRH documents.

http://dl.dropbox.com/u/2843911/CDRH.zip
I think that labby does not need the safety features. never seen a labby with a shutter
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Old 01-11-2011, 07:32 PM #5
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Default Re: What is required to legally sell a class 4 laser product

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Originally Posted by Leodahsan View Post
I think that labby does not need the safety features. never seen a labby with a shutter
Then every labby you've seen would be illegal for sale as a stand-alone unit in the US. Lasers without these features can be sold legally in the US as OEM components, which means they MUST be incorporated into a finished product that IS legal to sell in the US. If a person imports or sells OEM lasers in the US by marketing them as stand-alone systems, they are in violation of the law. Of course that's not to say it doesn't happen quite often, but it is illegal nonetheless.

To recap:

OEM lasers are laser sources without the necessary features to be sold as stand-alone units. These are legal for sale as components in larger, FDA compliant systems. The VAST majority of lasers we see here on LPF (besides complete pointers/portables) are of the OEM variety.

Laser Systems/Laser Products are FDA approved stand-alone laser devices, which must contain all necessary safety features and comply with all CDRH regulations BEFORE they can be sold legally.
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Last edited by ElektroFreak; 01-11-2011 at 07:40 PM.
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Old 01-11-2011, 07:41 PM #6
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Default Re: What is required to legally sell a class 4 laser product

the current module has a toggle on/off switch, key to arm, BNC interlock/modulation, Red/green indicator, and electronic aperture shutter. I assume this meets requirements. The control box is also separate from the emission device. Ive looked over FDA a bit and it seems to have all kinds of laser uses listed. I cannot know the end use for all my customers, so how should i register if it could be used in Telecom, Military, and or medical?
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Old 01-11-2011, 08:36 PM #7
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Default Re: What is required to legally sell a class 4 laser product

LOL I forgot the key switch in the list above.. The only thing I don't see in your description is a time delay between throwing the switch to start emission and the time that emission begins. Other than that I think you're good, but I'm not a CDRH rep. My partner did just go through the process of obtaining variances for a few of our laser projectors, so I'm fairly sure that the list above is complete, but the way they've been changing things lately coupled with a lack of funds and manpower means there's no way to be 100% sure except to submit a report and have the CDRH let you know if you're all good.
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Old 01-12-2011, 06:17 AM #8
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Default Re: What is required to legally sell a class 4 laser product

Next thing will be a DNA sample and an anal cavity scan to insure you are the registered owner and are trained to use such a device.
Why do laws only ever screw over the law abiding?
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Old 01-12-2011, 06:55 AM #9
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Default Re: What is required to legally sell a class 4 laser product

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Originally Posted by AUTO XX View Post
Next thing will be a DNA sample and an anal cavity scan to insure you are the registered owner and are trained to use such a device.
Why do laws only ever screw over the law abiding?
These laws don't screw over the law abiding. They're meant to keep standards so that safety regulations are followed, and so faulty and dangerous products aren't legally sanction to be sold on US soil. Just because these standards and regulations may be a pain for hobbiest-turned-professional laser sellers doesn't mean these laws are out of whack. It just means that hobbiests are straying into territory that has traditionally been the field of larger manufacturers who take these laws very seriously.

If anything, the real problem is that these laws and regulations are not being enforced so that the law-abiding good citizens/manufacturers are not being unfairly punished compared to the likes of sleazebag companies like Wicked Lasers that have to mislabel their packages so that customs won't confiscate their product at the border.
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Old 01-12-2011, 07:45 AM #10
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Default Re: What is required to legally sell a class 4 laser product

Uhm ..... wondering how much time need, before they add to the "required safety gadgets" a 220db foghorn-type siren and a motorized self-waving red flag ..... plus, maybe, a sat-tracker that send to police a SMS with your position all the times you turn it on
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Old 01-12-2011, 09:57 AM #11
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Default Re: What is required to legally sell a class 4 laser product

Quote:
Originally Posted by HIMNL9 View Post
Uhm ..... wondering how much time need, before they add to the "required safety gadgets" a 220db foghorn-type siren and a motorized self-waving red flag ..... plus, maybe, a sat-tracker that send to police a SMS with your position all the times you turn it on
Dammit man! Don't give them any ideas!!


Don't listen to me, I have only ever seen cops and courts screw up something simple or make a bad situation worse.
My opinion on them is: I would help 99% of the general population without thinking about it but if a cop needed my help.....
I might just walk away.
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Old 01-12-2011, 10:35 AM #12
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Default Re: What is required to legally sell a class 4 laser product

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Old 01-12-2011, 04:37 PM #13
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Default Re: What is required to legally sell a class 4 laser product

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Originally Posted by AUTO XX View Post
Don't listen to me, I have only ever seen cops and courts screw up something simple or make a bad situation worse.
My opinion on them is: I would help 99% of the general population without thinking about it but if a cop needed my help.....
I might just walk away.
The most corrupt cops are the ones who do not apply the law fairly because of prejudices. You're acting just like that.
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Old 01-12-2011, 10:19 PM #14
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Default Re: What is required to legally sell a class 4 laser product

autoxx, thank the lord that you don't live in a glass house my man.


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Old 01-13-2011, 01:50 PM #15
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Default Re: What is required to legally sell a class 4 laser product

Your FDA Regional Electro Optical Specialist is supposed to be at 214-253-4930 and based out of Dallas. One of the supposed duties of a EOS is to assist manufacturers. The EOS does not work directly for CDRH, they work for the enforcement arm of FDA and do the field work and inspections of manufacturers. Thus they tend to answer phone calls within a few days and get back to you without issues.

They can guide you on the manufacturing report if you have questions.


I'm not sure if the Dallas office is staffed right now, but you should try.


I'd read laser notice 50 and laser notice 55 and see if you can start manufacture before the paperwork is approved, because of a serious backlog in DC at a underfunded agency.


Texas has a state laser safety program, and you MAY need to register with them. There is a fee per year, End users tell me 300-600$ per year depending on whom you talk to. Just don't pay it "per laser made" because you are a manufacturer, not a end user.

Radiation Control Program Home Page

http://www.dshs.state.tx.us/radiatio...01fn_10_08.pdf

Do not let them push you around, you are providing income and taxes for your state.

If you need a industrial laser safety consultant, this guy is really, really good:

Casey Stack,

http://www.lasercompliance.com/lc-about.htm

Casey can give you a quick, accurate picture of the industrial laser situation right now. Often he can save you time, because some people end up overdoing the paperwork side of things. Even if you don't hire him, he will have the latest contact info for FDA's offices.

Some OEM telcom lasers may just need a simple set of warning stickers, no keys, no shutter, etc. It really depends if its public access and what it is used for. If its buried underground in a vault for the next 20 years, it is a bit senseless to add some of the human access safety features. Hence my suggestion of a consultant.


Note to end user type LPF members, bugging a EOS with random laser pointer questions could be hazardous to your legal health, they have a federal badge. They have a mandate to help actual device manufacturers, so SWSHOUSE can call a EOS with no fear of repercussions.

And for whomever said "Sirens and Blinking red lights", I have a FDA document some place that states if the warning horn or warning light is a greater hazard then the actual laser, its purpose is defeated. You only need enough warning for the operator, not the whole planet. Thus moderation is allowed and encouraged. No one is going to ask for a ball and chain or a blinding warning beacon.

Steve

Last edited by LSRFAQ; 01-13-2011 at 02:26 PM.
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