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Thread: Laser Variance

  1. #1
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    Default Laser Variance

    Hi.

    I am looking to add a few small lasers to my lighting system. They will be two 50mW greens and a 400mW RGY. I know that to use these I need an FDA variance. I'm confused though. Do I get the laser units first and then the variance, or do I get the variance first and then the lasers?

    Also, has anyone in America bought from a foreign supplier (Laserworld)? Are there any complications shipping in a laser from Europe?

    Thanks a lot,
    -Jeff

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    Lightbulb

    Welcome Jeff. I am NO expert, but I am fairly certain you get the laser first, make sure it has all the components needed for "legal" laser projector, then get it varienced.
    Love, peace, and grease,

    allthat... aka: aaron@pangolin

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    variance first, but you need to know what hardware you will be using and it must have a cdrh acession number before filing. Unless you want to go through the mess of building your own, in which case you file a manufacturers report before or when you do the vari. You can file a
    manufacturers report for non compliant commercial gear after you buy it, ie buy it and make it compliant and put down your own serial number etc. Technically they should not ship you the gear till you have the vari, but cdrh is understaffed. With the way the climate is changing after the moscow incident, get your vari if you want to do any lasers in the future.

    I have a friend that files variances commercially at a reasonable cost, including mine. PM me and I'll link you up.

    Steve

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    Listen to the Man here "^" WAY before you listen to what I post.

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    well unless your getting them from a U.S. mfg or a foreign mfg that has a U.S. product variance( acession number ) then its going to be difficult to get it legal you will need to write your own product variance not your just lightshow variance basically making you the mfg of that product (even if you didn't build it) and you have to prove to the gov why its safe to use it in public explaining all the safety features if they don't exists you have to implement them ie install a shutter (most stuff out of china doesn't have a CDRH approved shutter or any shutter for that mater)there is a lot more to it(and lot of calculations) but thats the jist of it
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    John
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  6. #6
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    Thanks for the quick replies. It sounds like this can get very complicated. I've been looking over some online forms I've found regarding the variance application. It says I'll need a product report for each laser I use. Do I request that from the manufacturer and then submit it along with the rest of my application?

    Thanks,
    -Jeff

  7. #7
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    Jeff-

    here is a LINK that i posted a while back with some very useful forms and info.

    HOWEVER...its not as easy as just filling out a few forms.

    1. in order to get a Laser Light Show varaince, you need to tell the FDA/CDRH *WHICH* approved Laser Light Show equipment you plan on using.
    i dont know of ANY imported Laser systems (the pre-fab units) that come in that are already approved. Approved means that the manufacturer has ALREADY filled out a product report for that laser system and that product report HAS BEEN APPROVED. once a product report is approved for a specific laser projector, it will be given an accesion number. in essence, this is the variance # for THAT PROJECTOR. NOT, a variance for YOU (or anyone) to use that projector in public.

    OSLS sells an "LT1000" and "LT500" Laser Light Show projector. it is just the metal enclosure. BUT this is ALREADY approved by the FDA/CDRH as a Laser Light show projector and therefore has its own accession # (variance #) and is sold as a "Certifed Laser enclosure." and THEY ARE NOT CHEAP!!!! TRUST ME, after you do one or 2 product reports and see what goes into them, you will understand why pre-certified projectors are exponentially more expensive.

    2. if you try to get a variance for a non-certified laser system, it WILL NOT BE APPROVED. ESPECIALLY (and i WILL NOT mention any names) if it is one of the manufacturers on the FDA's list for illegal imports of lasers and/or systems. is it possible for it to squeak by and maybe be approved if it is *only* a 50mW simple green system? possibly, but doubtful.

    3. hypothetically-

    once you obtain a CERTIFED laser system or build one (and do the proper product reports and approvals) yourself, you then need to do a laser light show report and fill out your 4 page variance request. this variance request is asking permission in essence for you to use that APPROVED and deemed safe laser projector in a public venue. you will need (through your laser light show report) prove to the FDA/CDRH how the system will be used in a safe manner and what safety aspects are in use to guarantee safety.

    it seems like a lot of hassle, and it kinda is. BUT, its for a good reason. WAAAY too many (and im NOT saying you) ding-bats out there buy cheapo laser systems, turn them on at barmitzvahs and weddings and start blasting out high powered laser beams.

    does it mean that peoples eyes are being melted out of their heads? NOO. but is IS UNSAFE and it DOES pose a potential hazard. these restrictions and guidelines are to provide guidance, education and some sort of control over what could be dangerous pieces of equipment.

    -Marc
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    Quote Originally Posted by gottaluvlasers View Post
    OSLS sells an "LT1000" and "LT500" Laser Light Show projector. it is just the metal enclosure. BUT this is ALREADY approved by the FDA/CDRH as a Laser Light show projector and therefore has its own accession # (variance #) and is sold as a "Certifed Laser enclosure." and THEY ARE NOT CHEAP!!!! TRUST ME, after you do one or 2 product reports and see what goes into them, you will understand why pre-certified projectors are exponentially more expensive.
    Ah! That answers a lot. I was wondering why those enclosures were so expensive. Now I get it. Obviously a loophole in the system but I guess that works.

    Thanks for the info.
    Adam

    Quote Originally Posted by prolightdesigner View Post
    Also, has anyone in America bought from a foreign supplier (Laserworld)? Are there any complications shipping in a laser from Europe?
    Many individuals on PL have indicated issues with LaserWorld products however, I have been very happy with my LW-50K scanners. They actually don't preform well over 30K but they are what I'd consider very good for the price. I have heard of rare occurrences with customs and lasers causing delays but the import issue seems to be just fine for now.
    Last edited by 300EVIL; 10-27-2008 at 19:19.

  9. #9
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    [QUOTE=prolightdesigner;66538]Thanks for the quick replies. It sounds like this can get very complicated. I've been looking over some online forms I've found regarding the variance application. It says I'll need a product report for each laser I use. Do I request that from the manufacturer and then submit it along with the rest of my application?

    If the manufacturer had done the work to get a accession number for their product, odds are they would be filing for you. Unless your very lucky, you'll have to prove compliance and write your own manufacturer's report, there are on line samples, and its not hard, just time consuming, and I think at this point if your have already purchased the lasers, your heading in the write it yourself direction. If there is a existing product report, yes you would send it in.

    Karl at Laserwizardry, www.laserwizardry.com, does this sort of thing at a reasonable cost.
    so do a few professional consultants, . Lasercompliance.com is one.

    Are you doing touring or fixed venue?

    laserworld is a ILDA member, so odds are they might just have the paperwork.

    One other thing, its rare, but if your package is opened by customs, and its not on the list,or doesnt have the import paperwork, they can be refused entry.
    Steve

  10. #10
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    Thanks again for the advice. These lasers would be intended for use on a mobile light system. No, I have not bought anything yet and want to make sure that I do all this in a safe and legal manner!

    So let me make sure I've got all this straight: The first thing I do is make sure the laser I want is FDA and CDRH compliant and if so obtain the accesion number. Then I fill out a show report and the four page variance application. Upon approval I buy the laser.

    One thing I'm not understanding is that if I need to get the variance before I can buy a laser, how can I get an un-certified laser up to par and certified without having it in my possession?

    -Jeff

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