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Looks like the FDA is finally fed up with handheld lasers...

pmurph5

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For Event_Horizon and others:

FDA's authority over lasers is set forth in 21 CFR 1040.10 and 1040.11. Over the years, FDA has tried to expand its interpretation of these regulations.

  • They first did it in the late 1980s, to define and regulate "pointers" even though the word "pointer" and the concept of using lasers solely to point are not listed in 1040.10 or 1040.11.
  • In 2009 they tried to assert authority over handheld lasers promoted for "amusement", even though that word does not appear in 1040.10 or 1040.11, and has a different meaning than "entertainment" which they can regulate.
  • Recently they seem to be asserting that any handheld laser falls into the SLA category when for many, many reasons they absolutely do not. For example, lasers used professionally for surveying, leveling and alignment do not look like handheld lasers unless there is also a special holder; without the holder it is not possible to do useful surveying, leveling or alignment. Also, the word "handheld" is not defined anywhere in 1040.10 or 1040.11, so it is not a defining element of being an SLA laser. Finally, just because a laser emits a straight line does not mean it is "defining" a straight line; otherwise, almost ALL lasers would be SLA lasers and this is clearly not the intent of 1040.10 and 1040.11

The only reason FDA has gotten away with this is that no one has called them on it. As far as I know, no person or company has seriously challenged FDA's expanding definitions; for example, by suing FDA for exceeding its stated authority and thus impeding commerce.

Could such a lawsuit succeed?

My opinion is that the definition of "pointer" is so entrenched it is not worth fighting. (E.g., FDA saying you can't sell a laser 5 mW or more as a "pointer" or for pointing purposes -- that will probably stay.)

But I believe that the FDA is clearly wrong in trying to stop "amusement" lasers and is especially wrong in trying to regulate handhelds as SLA lasers, based on a clear reading of the English language. More details on this are at http://www.laserpointersafety.com/perspectives/sla/sla.html

If my position is correct, then FDA must permit at the federal level the import and sale of any laser that is properly reported to FDA (e.g., a Laser Product Report, and Form 2877 if required), and that has all the correct labeling and safety features required for its Class. (Also, if the laser is 5 mW or more, it cannot be called a "pointer" or be sold for pointing purposes based on long-standing custom.)

Persons on this thread can get all upset about Big Government, and bemoan the fact that "they're coming for our lasers", etc. But until someone challenges FDA in a significant way, such as by legal action, all these complaints in this little tiny corner of the Internet will be meaningless in actually affecting change.

-- Patrick

PS: The above is my personal opinion. I am not speaking for any organization. Also, there are other important issues such as whether laser pointer sales need to be restricted due to excessive misuse. In this post above, I am simply discussing whether FDA is accurately following the definitions and Congressional grant of authority as listed in 1040.10 and 1040.11.
 



ultimatekaiser

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For Event_Horizon and others:

FDA's authority over lasers is set forth in 21 CFR 1040.10 and 1040.11. Over the years, FDA has tried to expand its interpretation of these regulations.

  • They first did it in the late 1980s, to define and regulate "pointers" even though the word "pointer" and the concept of using lasers solely to point are not listed in 1040.10 or 1040.11.
  • In 2009 they tried to assert authority over handheld lasers promoted for "amusement", even though that word does not appear in 1040.10 or 1040.11, and has a different meaning than "entertainment" which they can regulate.
  • Recently they seem to be asserting that any handheld laser falls into the SLA category when for many, many reasons they absolutely do not. For example, lasers used professionally for surveying, leveling and alignment do not look like handheld lasers unless there is also a special holder; without the holder it is not possible to do useful surveying, leveling or alignment. Also, the word "handheld" is not defined anywhere in 1040.10 or 1040.11, so it is not a defining element of being an SLA laser. Finally, just because a laser emits a straight line does not mean it is "defining" a straight line; otherwise, almost ALL lasers would be SLA lasers and this is clearly not the intent of 1040.10 and 1040.11

The only reason FDA has gotten away with this is that no one has called them on it. As far as I know, no person or company has seriously challenged FDA's expanding definitions; for example, by suing FDA for exceeding its stated authority and thus impeding commerce.

Could such a lawsuit succeed?

My opinion is that the definition of "pointer" is so entrenched it is not worth fighting. (E.g., FDA saying you can't sell a laser 5 mW or more as a "pointer" or for pointing purposes -- that will probably stay.)

But I believe that the FDA is clearly wrong in trying to stop "amusement" lasers and is especially wrong in trying to regulate handhelds as SLA lasers, based on a clear reading of the English language. More details on this are at http://www.laserpointersafety.com/perspectives/sla/sla.html

If my position is correct, then FDA must permit at the federal level the import and sale of any laser that is properly reported to FDA (e.g., a Laser Product Report, and Form 2877 if required), and that has all the correct labeling and safety features required for its Class. (Also, if the laser is 5 mW or more, it cannot be called a "pointer" or be sold for pointing purposes based on long-standing custom.)

Persons on this thread can get all upset about Big Government, and bemoan the fact that "they're coming for our lasers", etc. But until someone challenges FDA in a significant way, such as by legal action, all these complaints in this little tiny corner of the Internet will be meaningless in actually affecting change.

-- Patrick

PS: The above is my personal opinion. I am not speaking for any organization. Also, there are other important issues such as whether laser pointer sales need to be restricted due to excessive misuse. In this post above, I am simply discussing whether FDA is accurately following the definitions and Congressional grant of authority as listed in 1040.10 and 1040.11.

this is pretty much my views too. nowhere does it say anything about that. bottom line is that lasers that meet the standard can be registered, which are then legal, no ifs, ands, or buts. that is subject to change of course if congress were to change the CFRs, but for now...it stands as is. and even if they do remove these at some point...they shouldnt take them away without providing a license or alternate of some kind that would allow people with a legit reason to have one, and/or know the responsibilities of having them to use the modules if need be, like a driver license does.
 
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hwang21

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Which is exactly what I'm proposing. First the FDA needs to restrict public market and access to any lasers over 5mW. Second, the FDA should create a licensing system to permit responsible and educated laser owners to own and operate lasers over 5mW
 

OrionBLF

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I actually ran into a dick on a local gun forum I belong to that was giving me shit when I posted pictures of my lasers. Well this guy comes out of no where and starts telling me how lasers are so dangerous and why would I want something that powerful.... blah blah blah. I was beside myself, a guy on a gun forum was giving me crap about lasers (I am pretty sure a bullet will do a little more damage). I treat my lasers as I would a gun and lasers are dangerous in the wrong hands but worse accidents have come from firearms then lasers. This is just my opinion.

He's just jealous cos bullets will never reach the target at the speed of light!
 

Spooky

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I tend to agree with Patrick, the word "amusement" is the problem.

If they can make the word "amusement" stick then bringing suit is likely the only way things will change.The word "pointer" stuck and now seems to be used to regulate (even though as Patrick pointed out such systems were not available at the time of legislation)

cheers

Dave
 

Blaster

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But I never had it yet, and it's being fixed outside the U.S.
best of luck i was about to buy the same laser as yours but with the latest saga im not going to chance an item of that price any more i have to wait and see what peoples experiences are like does it get through or grabbed, I'm in Australia and as far as I'm aware our customs are even worse than yours I've lost 4 and 7 have gotten in an item of this price nearly 1000 dollars Australian money is just to much of a risk to try it ..
 
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Blackwolf

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We should acquire our own CNI reseller like Laserglow In America.
 

Event_Horizon

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As far as I know, no person or company has seriously challenged FDA's expanding definitions; for example, by suing FDA for exceeding its stated authority and thus impeding commerce.

Could such a lawsuit succeed?

Such a lawsuit would be very expensive regardless of whether it succeeded or not.
 

ixfd64

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Such a lawsuit would be very expensive regardless of whether it succeeded or not.

One can only hope there's a lawyer among us that's willing to do pro bono work.

P.S. I take it that Laserglow isn't the kind of company that would be willing to stick class IIIa labels onto IIIb products to get around the restrictions?
 

Spooky

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Such a lawsuit would be very expensive regardless of whether it succeeded or not.

It would also bring lasers right to the very front of peoples minds, that isn't always a good thing.
Who here could stand up in court and give a definitive legitimate reason for anybody to own a 5 watt blue laser pen?

"I like them" "they are fun" "balloon popping is great" "I find the pretty colours interesting" "It helps me learn about lasers" "I collect wavelengths" "I'm the next George Lucas"

Very few if any of the reasons most of us here would use would stand up as supporting evidence for not banning high power lasers completely.

(devils advocate) If anybody has a grounded reason for not banning high power pointers that cannot be addressed by

1: Using the same wavelength in a lower power

or

2: Using a lab laser

I'd love to hear it, lets try it the other way round...

Imagine the Judge is reading this thread, and want's to know what legitimate justification anybody has for owning a 3 watt laser compared to a 5mW laser in the same wavelength? if there is one it would be fantastic as that could be used to fight legislation (interpretation)

I'm all for owning whatever any responsible person wants but to survive as a legitimate, responsible hobby all of us need a firm base to fight from. Without it the end result isn't good.

cheers

Dave
 

Spooky

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P.S. I take it that Laserglow isn't the kind of company that would be willing to stick class IIIa labels onto IIIb products to get around the restrictions?

No reputable company is going to risk the fallout from circumventing the law just for the sake of a few sales. Doing that kind of thing with duel purpose exports can land you on the watch list uber quickly.

cheers

Dave
 

ultimatekaiser

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It would also bring lasers right to the very front of peoples minds, that isn't always a good thing.
Who here could stand up in court and give a definitive legitimate reason for anybody to own a 5 watt blue laser pen?

"I like them" "they are fun" "balloon popping is great" "I find the pretty colours interesting" "It helps me learn about lasers" "I collect wavelengths" "I'm the next George Lucas"

Very few if any of the reasons most of us here would use would stand up as supporting evidence for not banning high power lasers completely.

(devils advocate) If anybody has a grounded reason for not banning high power pointers that cannot be addressed by

1: Using the same wavelength in a lower power

or

2: Using a lab laser

I'd love to hear it, lets try it the other way round...

Imagine the Judge is reading this thread, and want's to know what legitimate justification anybody has for owning a 3 watt laser compared to a 5mW laser in the same wavelength? if there is one it would be fantastic as that could be used to fight legislation (interpretation)

I'm all for owning whatever any responsible person wants but to survive as a legitimate, responsible hobby all of us need a firm base to fight from. Without it the end result isn't good.

cheers

Dave

Well frankly I doubt anyone outside a lab needs a class 4 laser in a portable format. A class IIIb maybe....
 

Blaster

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Tiny part of the problem to be honest is the classes themselves i mean class 3b is 5mw cat chase toy to 500 mW eye frying beast, there a problem with the class ranges that needs to be sorted out
 

Event_Horizon

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(devils advocate) If anybody has a grounded reason for not banning high power pointers that cannot be addressed by

1: Using the same wavelength in a lower power

or

2: Using a lab laser

I'd love to hear it, lets try it the other way round...

A large portion of the people who buy (bought?) those products from Laserglow use them for bird abatement. Farmers, golf course owners, even airport operators use them to frighten away birds from long range. Another legitimate use is long-range microwave antenna alignment. If you need to line up your antenna with another one 3 miles away, you can just attach a laser to it and look for the reflection to get it very close to perfect.

ifxd64 said:
P.S. I take it that Laserglow isn't the kind of company that would be willing to stick class IIIa labels onto IIIb products to get around the restrictions?

Not a chance. We don't want to get put onto the FDA's "hit list" because we don't want our other business (lab lasers, IIIa pointers, alignment products) getting stopped at customs.
 

ultimatekaiser

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I kinda agree. There is a huge gap there, and its not like there's some huge wall at half a watt of emissions that suddenly changes the rules. Safety should be followed no matter how powerful it is. Just like a gun. Number one rule is dont point it at anything you don't want destroyed. Similar principles are followed here.

And agreed, 5mw doesn't work well for tower alignments. Hell, the x10dr makes that a much easier task I'm sure. Especially on a clear evening/night

Personally I don't mind that I'd have my lasers in a labby format, but you'd need alot of outlets. And the other problem is budget. The cheapest lab module is usually twice the cost at least of a handheld equivelant.
 
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ixfd64

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Another idea is to sell the portable lasers as separate components that can be easily put together. I know BitLasers does this.
 




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