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FrozenGate by Avery

What are the Laws on Selling a Laser and Some Misc Questions

kuhny1

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Hey everyone,

So I have found my new website for getting laser parts called survivallaser.com and as I was going through their website, I noticed that there was a separate site for people in the US. I went there and noticed that there were no longer diodes or complete lasers. Then I realized that there is no law regarding the sale of LDs, only complete lasers. So then I thought about it more and also realized that the only law regarding the sale of complete pointers is that they cannot be imported over 5mw, right? I think that any laser can be shipped inside of the US without a problem, if not tell me what the law is about selling and shipping lasers inside the US is because I couldn't find anything.


On a unrelated note (regarding another law),

I've been going down to Ocean City Maryland for the past 6 years now and 4 years ago i had not seen one laser. I brought my 5mw green down there that year. Then the next year I went, there where green lasers everywhere. Every single store had been selling them. So obviously it didnt take long for some ignorant and just plain stupid people to shine them at peoples faces and at aircraft (or cars). So then around 2 years later OCMD set down a local law pretty much flat out banned lasers (link to the overview below). The thing is though they dont just come out and say its banned, they have to make it seem like, yeah you can have a laser but you have to be 18 or older and cant use it, just sit there and stare at it... Really? Why not just say they are banned. Thats just teasing people that like to use lasers responsibly.

Something I dont understand is, if you would shine a laser at an aircraft (which I would never do or anyone should ever do) how would it blind a pilot, I mean the fuselage would block the laser because its hitting the bottom of the aircraft. The only way a pilot could get hit is if someone had a direct shot to the windows which is only possible if you could fly... So i think that some pilots do overreact.

The overview
 





Hey everyone,

So I have found my new website for getting laser parts called survivallaser.com and as I was going through their website, I noticed that there was a separate site for people in the US. I went there and noticed that there were no longer diodes or complete lasers. Then I realized that there is no law regarding the sale of LDs, only complete lasers. So then I thought about it more and also realized that the only law regarding the sale of complete pointers is that they cannot be imported over 5mw, right? I think that any laser can be shipped inside of the US without a problem, if not tell me what the law is about selling and shipping lasers inside the US is because I couldn't find anything.

IIRC you can't sell complete lasers above 5mW in the US that don't have a variance from the FDA. Same goes for imports. IF you have the variance then it's all good. However - you wouldn't be granted a variance for just about any pointer - you need to meet the right specifications to get one (Key lock, interlock, start delay, emission indicator and shutter - may be others). Shipping a laser inside the US is technically fine, it doesn't go through customs. Components are also fine.

On a unrelated note (regarding another law),

I've been going down to Ocean City Maryland for the past 6 years now and 4 years ago i had not seen one laser. I brought my 5mw green down there that year. Then the next year I went, there where green lasers everywhere. Every single store had been selling them. So obviously it didnt take long for some ignorant and just plain stupid people to shine them at peoples faces and at aircraft (or cars). So then around 2 years later OCMD set down a local law pretty much flat out banned lasers (link to the overview below). The thing is though they dont just come out and say its banned, they have to make it seem like, yeah you can have a laser but you have to be 18 or older and cant use it, just sit there and stare at it... Really? Why not just say they are banned. Thats just teasing people that like to use lasers responsibly.

Something I dont understand is, if you would shine a laser at an aircraft (which I would never do or anyone should ever do) how would it blind a pilot, I mean the fuselage would block the laser because its hitting the bottom of the aircraft. The only way a pilot could get hit is if someone had a direct shot to the windows which is only possible if you could fly... So i think that some pilots do overreact.

I agree - I think some pilots do over react. However, the laser doesn't need to go directly into their eyes - it just needs to illuminate the cockpit - which is relatively easy on takeoff and approach. Imagine sitting in a fairly dimly lit room and all of a sudden someone shines a very bright light in your eyes. Can you see well after the light has been turned off? No - you've been flash blinded. It's temporary but it's also potentially very dangerous if you're doing something that requires you to see - such as landing an aircraft. Not to mention a big flashing light on the ground would be majorly distracting even if it didn't flash blind you.

The overview

Not sure about your local laws - someone else may be able to comment. :)
 
To answer your first question Diachi is 100% correct---hand held lasers >5mW can't be sold as items of commerce in USA without a variance and a variance is only given under certain circumstances. See : http://www.fda.gov/AboutFDA/Transparency/Basics/ucm302664.htm

Have a read of this page and other places of interest to you on the web site. I t will answer most of your questions: Laser Pointer Safety - FAQ

You can use also the LPF search function and find some detailed discussions about most any issue.

You are talking about Federal, State, and local laws and how they apply. You need to talk with the Lawmakers, in each case, to know WHY they wrote the laws they way they wrote them.
FAA web page has a lot of Aircraft related info https://www.faa.gov/about/initiatives/lasers/laws/
 
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Thanks for your reply :)


Does that mean that its perfectly legal for the shipment of lasers diodes? I wonder why survival laser wouldn't have diodes on their US site. Oh well, I'll have to order one and see if comes through I guess :D
 
Thanks for your reply :)


Does that mean that its perfectly legal for the shipment of lasers diodes? I wonder why survival laser wouldn't have diodes on their US site. Oh well, I'll have to order one and see if comes through I guess :D

Yes, entirely legal to ship components such as diodes - which actually includes fully functional "OEM" modules - parts which are intended to be integrated into another system.

Not sure why the Survival Lasers USA site doesn't have diodes - maybe got bugged by the FDA or something for selling to people in the US - even though it's not against the law, I guess they could bug you about it.:confused:

DTR's store is the place to go for diodes anyway.
 
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Thanks for your reply :)


Does that mean that its perfectly legal for the shipment of lasers diodes? I wonder why survival laser wouldn't have diodes on their US site. Oh well, I'll have to order one and see if comes through I guess :D

Survival Lasers used to sell diodes, complete kits, and fully assembled lasers in the USA. THe FDA put and end to it. All you he can do in USA is sell everything but the diodes so he is not seen as selling complete lasers or kits for same.

As the owner of Survival Lasers said in post #13 here: http://laserpointerforums.com/f44/question-about-survival-lasers-88504.html

"you wouldn't think it was so stupid if you received a series of letters from the FDA (that's the U.S. Food and Drug Administration, the federal agency charged by Congress with the regulation of "radiation producing" products like lasers, among other things) threatening to fine you and/or shut you down if you didn't comply with their policy of selective interpretation and enforcement of their regulations.

Do you seriously think I would of my own free will turn down sales from my fellow citizens??

The SL USA site was specifically constructed after a number of exchanges with the FDA about what they would and would not consider violations of their regulations. We also racked up significant legal fees during this process.

The reason others here are still selling is that they are not yet on the FDA's radar, or are not selling a combination of parts that could be construed as "lasers" or "laser products" as the FDA defines them. If they continue long enough, or become visible enough, I'm sure they will be contacted as well.

If you are unhappy with this policy, I would recommend you contact the FDA and express your concern and opinion about their regulations and enforcement practices. We appreciate all the support we can get and we would love to be able to resume shipping all of our products to US customers. "

Kuhny1---As a result of FDA laws, rules, and regulations all you will find is one group of people selling hosts ans not diodes and another group selling just diode, drivers, other parts not including hosts.
 
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Yeah, just got a email back from asking why they stopped selling diodes. Here is the reply

Unfortunately this is not the case. If we sell diodes or complete kits on the US store the FDA will declare everything we sell to be “laser products” and therefore regulated. We have been through this before with the FDA and I do not want a repeat performance.
 
There's the option of manufacturing handheld lasers that fully comply with FDA regulations. That would allow Survival Lasers to operate as they wish they could.
 
There's the option of manufacturing handheld lasers that fully comply with FDA regulations. That would allow Survival Lasers to operate as they wish they could.

Simply manufacturing them isn't enough (I say simply, it adds a fair bit of complexity - at least if you're building the hosts yourself). You still need to get them approved by the FDA and it seems like they wouldn't necessarily need to grant approval, even if you comply with the regulations.
 
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Thanks
Simply manufacturing them isn't enough (I say simply, it adds a fair bit of complexity - at least if you're building the hosts yourself). You still need to get them approved by the FDA and it seems like they wouldn't necessarily need to grant approval, even if you comply with the regulations.

Such a pessimistic attitude. Have you inquired? Personally I'd rather buy from a domestic company than from a foreign one. I think if memory serves two main safety features required. One is a delay of a few seconds after the power switch is flipped and the other is a locking mechanism. You should look into it at least, you've nothing to lose by doing that. One more thing. The FDA purpose is to make sure products are safe, not prevent businesses from going business.
 
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Such a pessimistic attitude. Have you inquired? Personally I'd rather buy from a domestic company than from a foreign one. I think if memory serves two main safety features required. One is a delay of a few seconds after the power switch is flipped and the other is a locking mechanism. You should look into it at least, you've nothing to loose by doing that.

Steve001--The FDA has legal authority to determine what can and can't be sold in many catagories of commerce and products see: http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194879.htm

FDA has determined that hand held lasers with outputs >5mW is not safe and can not be sold as an item of commerce in the USA without a variance on a case by case basis and even then only for certain purposes.

In the USA. there are real economic viability and legal reasons nobody in USA makes or sells handheld laser > 5mW as items of commerce.

As Diachi says it is not as simply as you imagine even just to get legally sellable output of 5mW or less. There is a mountain of paperwork, typically 50 pages, involved in geting even those if manufactured and sold in USA approved.

have a look at this: Does FDA regulate these new powerful laser "pointers" and are they hazardous?
and look espiciallyat this to gain some real perspective on what is required: U.S. laser laws and regulations If ILDA login screen comes up, just cancel it to see the page.

For higher output powers >5mW a variance is need for each and every instance/sale another time consuming bunch of paperwork and An annual report is required every year and so on and so on. They are only given in a handful of circumstances.

You can find additional info on this FDA web site: Laser Light Shows
 
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Steve001--The FDA has legal authority to determine what can and can't be sold in many catagories of commerce and products see: What does FDA regulate?

FDA has determined that hand held lasers with outputs >5mW is not safe and can not be sold as an item of commerce in the USA without a variance on a case by case basis and even then only for certain purposes.

In the USA. there are real economic viability and legal reasons nobody in USA makes or sells handheld laser > 5mW as items of commerce.
I wonder how one company I know does it?

As Diachi says it is not as simply as you imagine even just to get legally sellable output of 5mW or less. There is a mountain of paperwork, typically 50 pages, involved in geting even those if manufactured and sold in USA approved.
Show me a link to the paperwork. Paperwork is involved in running a business. As far as I can determine the FDA would have no reason to stop commerce if such a product meets the requirements.

have a look at this: Does FDA regulate these new powerful laser "pointers" and are they hazardous?
and look espiciallyat this to gain some real perspective on what is required: U.S. laser laws and regulations If ILDA login screen comes up, just cancel it to see the page.

For higher output powers >5mW a variance is need for each and every instance/sale another time consuming bunch of paperwork and An annual report is required every year and so on and so on. They are only given in a handful of circumstances.
True as I understand the rules ( I'll have to review them again). But that doesn't mean every time a sale is made someone has to type out a variance. It likely means this. Once a particular laser product is reviewed and approved a variance is given and the manufacturer prints out the variance (if the variance needs to be sent to the buyer). Yes, paperwork is involved with running a business. The red part. I think you are conflating inaccurately hobbyist lasers with lasers shows. I didn't say it would be easy, but to say from the start it's to hard isn't for you or I to say. I'll leave that up to Survival Lasers and other would be entrepreneurs

You can find additional info on this FDA web site: Laser Light Shows
We're not creating public laser light shows with our handheld lasers so this link has no bearing on the subject.
 
I wonder how one company I know does it?

Show me a link to the paperwork. Paperwork is involved in running a business. As far as I can determine the FDA would have no reason to stop commerce if such a product meets the requirements.

True as I understand the rules ( I'll have to review them again). But that doesn't mean every time a sale is made someone has to type out a variance. It likely means this. Once a particular laser product is reviewed and approved a variance is given and the manufacturer prints out the variance (if the variance needs to be sent to the buyer). Yes, paperwork is involved with running a business. The red part. I think you are conflating inaccurately hobbyist lasers with lasers shows. I didn't say it would be easy, but to say from the start it's to hard isn't for you or I to say. I'll leave that up to Survival Lasers and other would be entrepreneurs.

Survival Lasers told you what the result of back and forth with FDA was in the real world and I posted a link to a thread where they say more about it. How much more do you need to know---the FDA said "no" to Survival Lasers. Here is the link again, see post #13 http://laserpointerforums.com/f44/question-about-survival-lasers-88504.html

FDA says outright here: Does FDA regulate these new powerful laser "pointers" and are they hazardous?
"FDA regulates all laser products, even handheld, battery-powered lasers that are available for purchase FROM manufacturers, importers, assemblers, dealers or distributors in the United States and its territories. This includes lasers manufactured or obtained on a continuing basis for the purpose of sale or resale.

FDA requires that manufacturers of these lasers limit the power of the laser light to 5 milliWatts (often abbreviated as "mW") or less"

"Do not purchase a handheld, battery-powered laser labeled with hazard Class IIIb, Class IV, Class 1M, Class 2M, Class 3B or Class 4 unless the manufacturer has an approval from FDA (called a "variance") to allow the purchase. Lasers approved for purchase in these classes often have very specific uses and may be sold under certain conditions known to the manufacturer. Sales without a variance, or sales that violate the conditions of the variance, ARE ILLEGAL"

FDA changed their descriptions and interpretation of those descriptions to cover all possibilities including laser pointers--no more loopholes.

See also Important Information for Laser pointer Manufacturers here:Important Information for Laser Pointer Manufacturers
"Laser pointers are hand-held lasers that are promoted for pointing out objects or locations. Such laser products can meet one of two definitions for laser products. The first is for “surveying, leveling, and alignment laser products” as defined by Title 21 of the Code of Federal Regulations (CFR) Section 1040.10(b)(39):

“Surveying, leveling, or alignment laser product means a laser product manufactured, designed, intended or promoted for one or more of the following uses:
(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another.
(iii) Defining a plane, level, elevation, or straight line.”

Hand-held lasers promoted for entertainment purposes or amusement also meet the second definition, that of “demonstration laser products” as defined by 21 CFR 1040.10(b)(13):

“Demonstration laser product means a laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.

"If a laser product is promoted for pointing purposes, either of these definitions can apply."

"21 CFR 1040.11(b) and 1040.11(c), limit surveying, leveling, and alignment, and demonstration laser products to Class IIIa. This means that pointers are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers. There are also limits for any invisible wavelengths and for short pulses. Pointers may not exceed the accessible emission limits of CDRH Class IIIa or IEC1 Class 3R."

"Class IIIb hand-held lasers are too dangerous for use as pointers or amusement articles. Furthermore, promotion of Class IIIb or IEC Class 3B products for pointing or amusement violates FDA requirements and United States law. Manufacturers of such products may be required to repair, replace, or refund the purchase price of violative products distributed in the U.S. These products are also subject to detention and seizure by the U.S. Customs and Border Protection when imported."

You can imagine anything you want but no matter which category (demonstration or SLA) is applied, the result is to restrict the laser’s power to less than 5 milliwatts of visible light under current FDA laws, rules, and regulations. You can find links to al the rules and regulations here: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/LaserProductsandInstruments/default.htm

General variance information is here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=1010.4

As a practical matter why would any USA commercial manufacturer want to go through doing all the associated FDA requirements, paperwork, and testing involved only to have, if they pass muster, a product that is not even close to being cost competitive in the world market due to the high cost of FDA laws, rules , and regulations compliance???

Even US laser dazzlers makers have had it handed to them by FDA.
See what FDA sent to one guy doing a start up dazzler business here: http://www.fda.gov/iceci/enforcementactions/warningletters/2012/ucm341876.htm
 
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Survival Lasers told you what the result of back and forth with FDA was in the real world and I posted a link to a thread where they say more about it. How much more do you need to know---the FDA said No to Survival Lasers. Here is the link again, see post #13 http://laserpointerforums.com/f44/question-about-survival-lasers-88504.html

FDA says outright here: Does FDA regulate these new powerful laser "pointers" and are they hazardous?
"FDA regulates all laser products, even handheld, battery-powered lasers that are available for purchase FROM manufacturers, importers, assemblers, dealers or distributors in the United States and its territories. This includes lasers manufactured or obtained on a continuing basis for the purpose of sale or resale.

FDA requires that manufacturers of these lasers limit the power of the laser light to 5 milliWatts (often abbreviated as "mW") or less"

"Do not purchase a handheld, battery-powered laser labeled with hazard Class IIIb, Class IV, Class 1M, Class 2M, Class 3B or Class 4 unless the manufacturer has an approval from FDA (called a "variance") to allow the purchase. Lasers approved for purchase in these classes often have very specific uses and may be sold under certain conditions known to the manufacturer. Sales without a variance, or sales that violate the conditions of the variance, ARE ILLEGAL"

They changed their policy regarding battery powered hand held lasers to cover all possibilities as of 2010. See: Laser Pointer Safety - U.S. regulatory agencies

See also Important Information for Laser pointer Manufacturers here:Important Information for Laser Pointer Manufacturers
"Laser pointers are hand-held lasers that are promoted for pointing out objects or locations. Such laser products can meet one of two definitions for laser products. The first is for “surveying, leveling, and alignment laser products” as defined by Title 21 of the Code of Federal Regulations (CFR) Section 1040.10(b)(39):

“Surveying, leveling, or alignment laser product means a laser product manufactured, designed, intended or promoted for one or more of the following uses:
(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another.
(iii) Defining a plane, level, elevation, or straight line.”

Hand-held lasers promoted for entertainment purposes or amusement also meet the second definition, that of “demonstration laser products” as defined by 21 CFR 1040.10(b)(13):

“Demonstration laser product means a laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.

"If a laser product is promoted for pointing purposes, either of these definitions can apply."

"21 CFR 1040.11(b) and 1040.11(c), limit surveying, leveling, and alignment, and demonstration laser products to Class IIIa. This means that pointers are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers. There are also limits for any invisible wavelengths and for short pulses. Pointers may not exceed the accessible emission limits of CDRH Class IIIa or IEC1 Class 3R."

"Class IIIb hand-held lasers are too dangerous for use as pointers or amusement articles. Furthermore, promotion of Class IIIb or IEC Class 3B products for pointing or amusement violates FDA requirements and United States law. Manufacturers of such products may be required to repair, replace, or refund the purchase price of violative products distributed in the U.S. These products are also subject to detention and seizure by the U.S. Customs and Border Protection when imported."

You can imagine anything you want but no matter which category (demonstration or SLA) is applied, the result is to restrict the laser’s power to less than 5 milliwatts of visible light under current FDA laws, rules, and regulations. You can find links to al the rules and regulations here: Laser Products and Instruments

General variance information is here: CFR - Code of Federal Regulations Title 21

You need to read carefully again what was said in that thread post 13. You also missed where it reads in that FDA page where it states handheld lasers over 5mW can be sold in the USA as long as they are compliant. Part of the specific txt is bolded. I also feel you are again misunderstanding certain parts of the other FDA document. The FDA is talking about certain specific uses such as shows, scientific applications, where as I recall one has to document application and for how long. Such documentation for handheld lasers would be overly burdensome for the FDA to constantly review. This debate reminds me of the one I had with the owner operator of a laser show business. The debate was whether it was legal to shine a class 3b laser into the sky without a variance. He insisted it was illegal. I said it was not. I think I finally convinced him he was wrong when I finally quoted someone of authority it was not. Now his misunderstanding was conflating the rules that govern a laser show to apply to the hobbyist. Can you imagine how burdensome it would be if law required every hobbyist to write up a variance, then send it off to the CDRH for review and burdensome for the CDRH to review and have to do that every time a hobbyist wanted to shine their laser into the sky. Thanks what the fellow should have realized in the first place. He could have avoided a lot of high blood pressure.
 
You need to read carefully again what was said in that thread post 13. You also missed where it reads in that FDA page where it states handheld lasers over 5mW can be sold in the USA as long as they are compliant. Part of the specific txt is bolded. I also feel you are again misunderstanding certain parts of the other FDA document. The FDA is talking about certain specific uses such as shows, scientific applications, where as I recall one has to document application and for how long. Such documentation for handheld lasers would be overly burdensome for the FDA to constantly review. This debate reminds me of the one I had with the owner operator of a laser show business. The debate was whether it was legal to shine a class 3b laser into the sky without a variance. He insisted it was illegal. I said it was not. I think I finally convinced him he was wrong when I finally quoted someone of authority it was not. Now his misunderstanding was conflating the rules that govern a laser show to apply to the hobbyist. Can you imagine how burdensome it would be if law required every hobbyist to write up a variance, then send it off to the CDRH for review and burdensome for the CDRH to review and have to do that every time a hobbyist wanted to shine their laser into the sky. Thanks what the fellow should have realized in the first place. He could have avoided a lot of high blood pressure.


Not to be repetitive just informational the most current explaination of "pointers " is:
"Laser pointers are hand-held lasers that are promoted for pointing out objects or locations. Such laser products can meet one of two definitions for laser products. The first is for “surveying, leveling, and alignment laser products” as defined by Title 21 of the Code of Federal Regulations (CFR) Section 1040.10(b)(39)"
“Surveying, leveling, or alignment laser product means a laser product manufactured, designed, intended or promoted for one or more of the following uses:
(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another.
(iii) Defining a plane, level, elevation, or straight line.”

Hand-held lasers promoted for entertainment purposes or amusement also meet the second definition, that of “demonstration laser products” as defined by 21 CFR 1040.10(b)(13):

“Demonstration laser product means a laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition. "

"21 CFR 1040.11(b) and 1040.11(c), limit surveying, leveling, and alignment, and demonstration laser products to Class IIIa. This means that pointers are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers. There are also limits for any invisible wavelengths and for short pulses. Pointers may not exceed the accessible emission limits of CDRH Class IIIa or IEC1 Class 3R."

"Class IIIb hand-held lasers are too dangerous for use as pointers or amusement articles. Furthermore, promotion of Class IIIb or IEC Class 3B products for pointing or amusement violates FDA requirements and United States law. Manufacturers of such products may be required to repair, replace, or refund the purchase price of violative products distributed in the U.S. These products are also subject to detention and seizure by the U.S. Customs and Border Protection when imported."

As pointed out here: http://www.laserpointersafety.com/FAQ/FAQ.html The botton line under the most current FDA laws, rules, and regulations is:
"Manufacturing and sales: Lasers sold to the public as "pointers" or for pointing purposes must be less than 5 milliwatts (5/1000 of a watt). This power is high enough so the laser "dot" is sufficiently visible for pointing out things, and is low enough to not be an eye hazard under conditions of accidental exposure. It is not intended or legal to sell lasers for pointing that are 5 milliwatts or more. Beginning in 2010, the FDA/CDRH is classifying handheld portable lasers as "surveying, leveling and alignment" (SLA) lasers, and may be trying to further restrict sales of lasers above 5 milliwatts based on this new rules interpretation.

Ownership: There is no federal law against owning a laser, of any power. (Some states and localities may have their own laws.) Therefore, at the federal level, an "illegal laser pointer" is illegal only from the manufacturer's or seller's standpoint. An "illegal" laser is too powerful to be sold or promoted for pointing purposes, or it may be lacking required safety features. If such a laser is sold to end users, the manufacturer may be required to do a recall, repair, replacement or refund. It is then up to the end user whether they wish to comply with the recall, repair, replacement or refund notice. [NOTE: This analysis is based on LaserPointerSafety.com's research. If you need specific legal advice, consult a lawyer with experience in this area.]"
 
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Not to be repetitive just informational the most current explaination of "pointers " is:
"Laser pointers are hand-held lasers that are promoted for pointing out objects or locations. Such laser products can meet one of two definitions for laser products. The first is for “surveying, leveling, and alignment laser products” as defined by Title 21 of the Code of Federal Regulations (CFR) Section 1040.10(b)(39)"
“Surveying, leveling, or alignment laser product means a laser product manufactured, designed, intended or promoted for one or more of the following uses:
(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another.
(iii) Defining a plane, level, elevation, or straight line.”

Hand-held lasers promoted for entertainment purposes or amusement also meet the second definition, that of “demonstration laser products” as defined by 21 CFR 1040.10(b)(13):

“Demonstration laser product means a laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition. "

"21 CFR 1040.11(b) and 1040.11(c), limit surveying, leveling, and alignment, and demonstration laser products to Class IIIa. This means that pointers are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers. There are also limits for any invisible wavelengths and for short pulses. Pointers may not exceed the accessible emission limits of CDRH Class IIIa or IEC1 Class 3R."

"Class IIIb hand-held lasers are too dangerous for use as pointers or amusement articles. Furthermore, promotion of Class IIIb or IEC Class 3B products for pointing or amusement violates FDA requirements and United States law. Manufacturers of such products may be required to repair, replace, or refund the purchase price of violative products distributed in the U.S. These products are also subject to detention and seizure by the U.S. Customs and Border Protection when imported."

As pointed out here: Laser Pointer Safety - FAQ The botton line under the most current FDA laws, rules, and regulations is:
"Manufacturing and sales: Lasers sold to the public as "pointers" or for pointing purposes must be less than 5 milliwatts (5/1000 of a watt). This power is high enough so the laser "dot" is sufficiently visible for pointing out things, and is low enough to not be an eye hazard under conditions of accidental exposure. It is not intended or legal to sell lasers for pointing that are 5 milliwatts or more. Beginning in 2010, the FDA/CDRH is classifying handheld portable lasers as "surveying, leveling and alignment" (SLA) lasers, and may be trying to further restrict sales of lasers above 5 milliwatts based on this new rules interpretation.

Ownership: There is no federal law against owning a laser, of any power. (Some states and localities may have their own laws.) Therefore, at the federal level, an "illegal laser pointer" is illegal only from the manufacturer's or seller's standpoint. An "illegal" laser is too powerful to be sold or promoted for pointing purposes, or it may be lacking required safety features. If such a laser is sold to end users, the manufacturer may be required to do a recall, repair, replacement or refund. It is then up to the end user whether they wish to comply with the recall, repair, replacement or refund notice. [NOTE: This analysis is based on LaserPointerSafety.com's research. If you need specific legal advice, consult a lawyer with experience in this area.]"
The point is we aren't talking about "laser pointers" we are discussing handheld battery operated lasers described briefly here.
Important Information for Laser Pointer Manufacturers Can battery-operated, portable laser systems be sold in the U.S?

Yes, battery-operated, portable laser systems can be sold in the U.S., providing that they fully comply with the standard, are certified and reported, and are not Class IIIb lasers sold or promoted for pointing or amusement purposes.

People who operate Class IIIb portable laser systems should be familiar with the above ANSI standards for safe use of lasers. This ANSI series of standards includes specific information for the safe use of such laser products in their applications of use.

1. IEC – International Electrotechnical Commission Standard 60825-1, Ed. 1.2: 2001-08

2. ANSI Z136 standards are available from the Laser Institute of America (www.laserinstitute.org)
It is doable.
 





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