U.S. Customs & Border Protection ....Seized my laser.... HELP!!

[buffo]

Marc, you should READ your manufacturers variance (if you have one).

*IF* he has one? Seriously?

Jesus Christ, do you have any idea who Marc is? He builds and sells laser projectors for a living for crying out loud. He has filed hundreds of product reports. (He's also currently serving on the ILDA committee for regulatory reform that Dan Goldsmith from X-laser is heading up.)

It sounds like you haven't been reading the very documents you've been suggesting to others, because Marc's advice (not to mention Frank's and Steve's) has been spot-on.

Read up on Laser Notice 50, Laser Notice 55, IEC 60825-1, and IEC 60601. Then brush up on the basics (21CFR 1040.10 and .11). After that, you need to familiarize yourself with Customs Form 2976. Then you might be in a better position to offer advice on the topic. Until then, you are only spreading bad information.

As for Laserguy216's problem, I agree with Frank (and others) who have pointed out that if the unit had shipped separately (Head and Driver separated), he would have been OK. Not sure what can be done at this point to remedy the situation though, apart from filing a belated 2976 form and praying for them (US customs) to be lenient...

Adam

[gottaluvlasers]

Laseguy216-

You purchased a "Lab Laser" which is not compliant here in the USA. What Lasever may have and/or MANY other Chinese companies are doing is outright lying to their customers about the compliancy (sp?) of their products. As Frank has very eloquently pointed out, a Laser can not be considered "OEM" if it can be taken out of the box and without "some sort of modification, or fabrication" plugged in (or power applied) and it lase. This is why all of these chinese companies that are saying their products are "FDA Approved" and supply nothing more than an accession number (if, even that) are doing nothing more than lying to potential customers. I am in the process of redoing ALL of my product reports for my systems and it has taken me close to a year. Do you really think chinese companies are doing product reports (actually, i *think* CNI has some legit, APPROVED systems)??

If a Laser can be taken out of its shipping container and relatively easily made to lase, than it needs to comply with US laws.

Couple things which may help us help you....

1) How many did you purchase? How many are in the package(s)? If its multiple units, it is probably going to be considered "for commerce" (meaning resale) and it is going to be very hard for you to pursuade them to let them go to you for your own personal use.

2) Was any sort of accession # provided by Lasever? If not, i would say with some confidence, the package will be sent back.

3) Have you talked to anyone through customs yet? If so, what did *you* say the package was??

4) Have you talked to Lasever? What are they saying?

5) Did you fill out the import radiaiton declaration form? I think Steve (mixedgas) posted it above. Again, if you have multiple units, its going to be very hard to import if they are not compliant.

-Marc

[slicklasers]

So now you are all agreeing with me and still saying i'm wrong?!? Time for me to leave you to your own accord again. Sorry for trying to help out. If you have any other issues, then just look up on CDRH Website. It is all there in BLACK AND WHITE, no GREY AREAS. I will take my 14+ years of experince and keep it to myself.

[buffo]

So now you are all agreeing with me and still saying i'm wrong?!?

No, they are disagreeing with this statement you made:

If you want to own any laser above 4.95mW in the USA you MUST HAVE A VARIANCE. Even if it is just for your home use. No US company may sell you a laser above 4.95mW unless you have a Variance.

This is demonstratably false. "Owning" a laser is not illegal under CDRH regulations. They can only regulate the SALE of lasers.

Furthermore, OEM components can legally be purchased by anyone and assembled in the home into a working laser. It is only when said laser is to be introduced into commerce that the CDRH has jurisdiction. (Remember that the CDRH gets *ALL* of it's authority through the commerce clause. They can't come into your home and prosecute you for building a death ray in your basement!)

As for importing lasers, the same principle holds: if you purchase OEM components from China for private use, you don't need to file a 2976. Most people just order the finished laser and chance it, but if they had the head and driver shipped separately, they would be legal.

Adam

[ShortyInCanada]

Hi guys. I'm just a dumb Canadian here reading all this and trying to anticipate the possible actions from Canada Customs in the near future (So maybe I'm not all that dumb afterall) for us Canucks...

Would it hurt for Laserguy to submit a written letter of intent stating that the parts are to be used in a projector unit and that he purchased them as "OEM" pieces. (Assuming that is his intentions of course.)
He could strengthen his arguement if he volunteered pictures of any project under construction and added references to proper rules and regulations pertaining to the future "variance" aquisition.
That way he might be seen as compliant with the current import rules to some extent and with some indication that he knows what he is doing (more than the customs agents do, at least) with the hardware.

Could it hurt his case ? Might it prove worthwhile to invest an hour in some documentation and composition of a letter ?

Looking forward to your replies.

[mixedgas]

Quote:
"Could it hurt his case ? Might it prove worthwhile to invest an hour in some documentation and composition of a letter ?"

He can try. HE would be well advised to see what X-Laser tells him.

Just about anything he does now would hurt his case if he does not have docs from the manufacturer.

He has a slight chance If AND ONLY IF he had a variance or a legitimate business or lab use. He would then be slapped for not filing the non-approved device import form before importing.

The non-compliant device form basically had/has three options (In the old days) 1. When your done it is exported back to country of origin and is in the States on "Bond". Two, its a OEM part and he's making it compliant. 3. Its destroyed.

If this were a 50K$ lab laser and a ignorant staff member or broker did not file the papers, that is one thing and might, after considerable work and time, be released. . But because this is a low cost device (Perhaps not to 216, but it is to the G.) that is considered a threat to public health or "Adulterated" he is going to have a serious problem trying to do that.

He could ask that it be returned to the maker, but it can even be destroyed. In rare cases, they have been released after a long delay, there is one case of that on LPF.

There is NO difference between a labbie , or a rangefinder, or a medical laser, and handhelds except for technical requirements, a laser is a laser is a laser. If you look at the hold list that used to be on the FDA laser site, even billion dollar a year commercial laser companies get holds.


Steve

[DanG]

Adam, what is a 2976? I cannot find that anywhere. Are you perhaps referring to an FDA-2877?

I think that the law is pretty clear in this case: You bought a product which, in the absence of other information qualifies as a complete laser device and thus is subject to the Federal regulatory standards. I assume that a 2877 was not filed for it which would get FDA to release the goods as Steve said. At this point, you are best off having them return the goods to the sender and then having them re-sent with the proper paperwork filed and without the power supply. That is, I think, going to be the fastest and simplest means of doing this. You can fight the power on this all day long but as the law exists presently, as I understand it, they are not wrong to seize the goods. Sorry bud.

Adam, I think you have overstated the case a little. Owning a non-compliant laser is a big problem if you yourself did not built it from OEM components. You are dead on right about the commerce clause but if someone were to buy a non-compliant laser from overseas, or even domestically, having it for home use does not exempt the product from Federal oversight under the commerce clause. As such it can be illegal to own a laser, especially if you don't have a variance, regardless of how it is being used if it came through some process of commerce. Your statement could be read to say that once you got it in hand, you were good as long as you didn't resell it.

[Bradfo69]

This is an extremely frustrating thread. Of course, I'm preaching to the choir and I hope that someday, in the future, efforts of Dan, Marc and others can bring about some clear change. The way I'm reading and interpreting it, basically every damn thing in the buy/sell thread is essentially illegal, unless the seller is a manufacturer and the buyer has some sort of varience.

If say, I buy a homebuilt projector from a member at a LEM it's illegal. If a hobbyist, say Blowfly buys a 100mW 473 module from Marc to eventually learn how to build, a varienced projector, it's illegal. He successfully built and got his projector varienced but, by definition, it wasn't legal for him to own the parts beforehand.

If an astronomy professor buys this 30mW keychain pointer from Aixiz in Houston http://www.aixiz.com/store/product_i...54b139e42c3265 it's illegal. What varience do they apply for in order to own this pointer? It just needs a battery to make it lase.

Or, what type of varience does a hunter get in order to get this Aixiz gun sight off Amazon.com?
http://www.amazon.com/Green-Laser-Si...7262665&sr=8-3 Again, it just needs a battery to make it lase. A lot of hunters I know think sitting in a tree with a beer at 5 in the morning, in the rain, at 37 degrees is a good idea so, I'm guessing some ain't bright enough to navigate the government forms.

I bought Smog's projector awhile back for example. I'd like nothing more than to do what is necessary to ensure it's made legal and get it varienced. I can't afford to pull a Dan (no offense) and throw a $4500 illegal box off the back loading dock. I know the CDRH supposedly reads these posts and now I'm "exposing myself" but, the ultimate intent here is: I WANNA DO THE RIGHT THING DAMMIT. MAKE IT EASIER!

Grr....
(Rant over, I'm better now. Well... a little.)

[flecom]

Rant

basically, after years of asking questions, reading documents, and other such research I am convinced theres no way to do anything 100% legal and correctly in lasers... its practically impossible... its more of a game of what can you get away with...

from what I have gathered the CDRH does *not* really care about lasers for display use, we are more of a nuisance to be dealt with than anything else...

[taggalucci]

They can't come into your home and prosecute you for building a death ray in your basement!

Phewww! A almost audible collective sigh of relief rang out from the lairs of many a PL'er!