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Old 01-05-2008, 06:49 PM #1
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Default How are >5mW lasers sold legally?

Hi all, I just read through the FDA laws (21CFR1040.10) on legal laser limits, which you can read for yourself here: http://www.accessdata.fda.gov/script...cfm?FR=1040.10 . *Basically, lasers under 5mW, such as the common Class-IIIa only require a label in the visible range, so that's fine. *But I am considering selling a few blu-ray violet pointers at about 10mW, which would be Class-IIIb and things are much more complicated there.

For such a 10mW laser, the requirements are a physical aperture block, a delay between activation and emission (that would REALLY annoying for presentations!!), a key switch to activate the power supply, and an interlock to stop the emission. *The emission delay is my biggest concern [21CFR1040.10(f)(5)(ii) -- (ii) Each laser system classified as a Class IIIb or IV laser product shall incorporate an emission indicator which provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I, and sufficiently prior to emission of such radiation to allow appropriate action to avoid exposure to the laser radiation.]. *Basically, an indicator must light first, then the beam can come out later. UGH!!!

So far, I've only seen all of these requirements from LaserGlow. *They have a cumbersome 5-point safety system that meets these FDA requirements (see http://www.laserglow.com/index.php?regulations). *But no one wants a delay before the beam comes out, or an interlock that you have to strap to your wrist! *

How does Wicked Lasers do it? *I couldn't find any info on their site. *How do other companies sell 100mW pointers legally in the US without adding these restrictive, cumbersome safety features without getting in trouble??

Maybe the best way is to tune the laser to 10mW, then put an attenuator (e.g., piece of clear green tape) over the aperture to get it down to 5mW and warn the user not to remove the attenuator. *Then if the end user removes the attenuator, that's their choice, but I won't get in trouble!


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Old 01-05-2008, 07:34 PM #2
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Default Re: How are >5mW lasers sold legally?

Simple answer: THEY DON'T!

There are some units like the RPLs which have an accession # to vary from the FDA laws so they can be imported legally. However, most III portable units in the US are effectively smuggled in. Not really an advanced smuggling operation - it normally just consists of shipping the laser in and hoping customs doesn't snatch it. But yeah, not at all legal if you want to read the letter of the law.
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Old 01-05-2008, 07:34 PM #3
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Default Re: How are >5mW lasers sold legally?

Well, optotronics has thos safety features, basicly anyone in the u.s. that sells them must, cep optotronics doesnt have an emission delay, the reason wickedlasers or novalasers (never by from wicked by the way horrible lasers worse customer service) is because there not in the u.s., novalasers is in canada and wicked is in china.

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Old 01-05-2008, 08:15 PM #4
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Default Re: How are >5mW lasers sold legally?

Quote:
Originally Posted by wooooooolazer
Well, optotronics has thos safety features, basicly anyone in the u.s. that sells them must, cep optotronics doesnt have an emission delay, the reason wickedlasers or novalasers (never by from wicked by the way horrible lasers worse customer service) is because there not in the u.s., novalasers is in canada and wicked is in china.

...lazer... ;D ;D ;D
Its not really about those safety features either really. Even with the mechanisms described in that 21 CFR 1040.10, you still need it registered with the FDA and have an accession number issued to legally import them as a laser for stand-alone non-research use.
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Old 01-05-2008, 09:37 PM #5
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Default Re: How are >5mW lasers sold legally?

Ah, but we can still build our own! ::evil grin:: And I'm heading toward 1+ watt territory!!

I also guess that if you want to sell them, you'd probably be best to keep a low profile, do not state the power levels in print, and ship only after you get a signed waiver of liability! (And proof of age!).

Good luck!
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Old 01-05-2008, 09:47 PM #6
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Default Re: How are >5mW lasers sold legally?

Sell them as a laser componet that way its not a fully functional one, just include the driver and diode seperatly, and when the person buys them just solder the 2 wires onto the wires coming off of the laser diode and your good to go.

Or just have a connector to put them together.

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Old 01-05-2008, 10:49 PM #7
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Default Re: How are >5mW lasers sold legally?

Respectable businesses follow the law, they don't skirt the law. How do you want to be known?
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Old 01-05-2008, 11:55 PM #8
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Default Re: How are >5mW lasers sold legally?

While I agree in principle, often laws are written that make it impossible for anyone without thousands of dollars to invest up front, to engage in a business. I'd say if he was going to really start a BUSINESS, then he should do the whole thing, but if he wants to sell half a dozen home-brew lasers on eBay to raise some $$$ for his hobby, I'd not call that disreputable, personally, but it's all how you look at it.

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Old 01-06-2008, 12:17 AM #9
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Default Re: How are >5mW lasers sold legally?

Yes, if your a businessnes then i would never do that, buy like xantos says just to sale a few things on ebay its not like your starting a whole business.

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Old 01-06-2008, 12:41 AM #10
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Default Re: How are >5mW lasers sold legally?

I thought I read somewhere that even if you break down the unit and sell it as pieces, if the buyer can assemble it to make it dangerous then it's the same as shipping it assembled in the first place. Or even if you "throttle" it down to sell it and all the buyer has to do is "throttle" it up to make it higher then that's the same thing also.
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Old 01-06-2008, 01:06 AM #11
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Default Re: How are >5mW lasers sold legally?

Quote:
Originally Posted by pseudonomen137
Its not really about those safety features either really. Even with the mechanisms described in that 21 CFR 1040.10, you still need it registered with the FDA and have an accession number issued to legally import them as a laser for stand-alone non-research use.
Okay, but where is this law, or where do I find out about accession numbers? *It's not in the CFR docs. *

No, I'm not interested in starting a full-blown buisness, but I didn't want to be branded an under-the-table 'illegal' dealer (hence I'm reading the CFR docs! *It's not becaue I'm bored!!). *I was hoping there would be some simple way to go from Class-IIIa to Class-IIIb, but it looks doubtful.

So what am I trying to sell?? *I'm working on a few novel concepts for laser pointers:
1. *A touch switch that makes use of the natural battery formed when you touch two dissimilar metals - this also prevents keys, loose change, etc from firing the pointer (they will produce 0v) and allows it to be easily waterproofed. *
2. *I also found an amazing single-chip switching supply that will run a single battery from full capacity down to just 0.3v! *
3. *I'm using the FET reverse-battery protection I described a few months ago - works GREAT! *
4. *I packed all of that onto a tiny PCB just 0.33" x 0.48" - Easily fits into the hull of the Aixiz housing, and maybe two of them will for the Red/Violet blu-rays! *
* I will have the complete plans available once I get everything tested. *I don't want to keep any buisness secrets, but all the SMD parts are WAY too small for most people on this forum, so I thought I would build a few and sell them. *I might try selling a few of the finished PCBs. *But I'm getting into the metal work too (latheing, milling) and want to make a few laser pointer housings.
* I'm also thinking about supplying the power via pseudo-capacitors, which can be around 100 Farads (yep 100F, not uF) at 2.5v, able to power a blu-ray pointer for about 20 minutes, and able to recharge in about 1 min by wallwort or 5min by USB port.

Ciao from MIT,
*colin
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Old 01-06-2008, 01:06 AM #12
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Default Re: How are >5mW lasers sold legally?

Good thing that mentality doesn't apply to what I can do with simple things I can buy at any grocery store!

<Momentary offtopic>Frothy - your YAG test on your website is AWESOME!</offtopic>

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Old 01-06-2008, 01:50 AM #13
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Default Re: How are >5mW lasers sold legally?

Hey i was thinking about using super-capacitors to, they wont last quite as long as a normal battery but when they can be charged up in a min or so it doesnt really matter.

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Old 01-07-2008, 02:56 PM #14
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Default Re: How are >5mW lasers sold legally?

Quote:
Originally Posted by Skram0
I thought I read somewhere that even if you break down the unit and sell it as pieces, if the buyer can assemble it to make it dangerous then it's the same as shipping it assembled in the first place. Or even if you "throttle" it down to sell it and all the buyer has to do is "throttle" it up to make it higher then that's the same thing also.
But can't then every pointer be "modded" to higher powers? Hardest would be to bridge (or change with lower value) the resistor limiting current to the diode.

besides that, cdanjo, your project sounds really cool - I bet you clould sell quite a few driver units (without the diode, saves trouble) in here.
But what do you mean with "pseudocaps"? Electric energy storage that hold as much energy as a 100F cap, with similar recharge times but doesn't have the 1/e-discharge curves?
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Old 03-12-2008, 11:55 PM #15
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Default Re: How are >5mW lasers sold legally?

ok as long as the units are sold as OEM units they are legal to sell just put this disclaimer in ur items description

You Accept this Laser as an OEM COMPONENT for integration in a system of YOUR OWN design and will be legally responsible for any and all LIABILITIES Our Laser Diodes and Modules are designed solely as an OEM component for incorporation into the customer's end products. Therefore, this laser does not comply with the appropriate requirements of FDA 21CFR, section 1040.10 and 1040.11 for complete laser products.
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Old 03-12-2008, 11:57 PM #16
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Default Re: How are >5mW lasers sold legally?

That's how Wickedlasers gets away with it, their lasers are 'OEM modules' and definitely not pen-style pointers, oh no, definitely not, no way.
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