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Thread: NON-Compliant Laserworld Projectors

  1. #1
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    Default NON-Compliant Laserworld Projectors

    After receving an inquiry from a customer regarding a Laser system build a few weeks ago and going through the whole sales pitch of quality and variances and legalities of USA Laser systems, This customer just would NOT "get it." They were asking why they could get a Laserworld projector for much less than one of my systems (or any other legitimate USA based Laser company) and argued my fact that Laserworlds systems are NOT legal here in the USA. Well, I have had it with all of these foreign companies shitting on me and all the other hard working Laser companies here in the U.S. so i am going to begin making PUBLIC the repsonses i get from the FDA regarding legalities of all of these supposed "FDA APPROVED" Foreign Laser companies. For which Laserworld IS NOT one of.

    I requested from the FDA, the "Approved status and variance approvals for Laserworld products" This is their response (with the letter to prove it)...

    “LaserWorld has no variance approvals for laser projectors it manufacturers that require a CDRH variance. A variance application from a laser light show manufacturer that cites use of a laser projector manufactured by LaserWorld would be approved on the condition that the laser light show did not use the LaserWorld projector (or its branded equivalent).

    Non-compliant products are not legal for sale in the U.S. therefore anyone who is now or has been in commerce with a Class IIIb or IV (3B or 4) LaserWorld demonstration laser product would be in violation of the Act because the manufacturer does not have a variance approval. Manufacturers, assemblers and importers may enter into commerce only with compliant products, and an approved variance is necessary for commerce with products that exceed certain class limits.

    Non-compliant products in commerce are subject to recall, repair or replacement by the manufacturer, and manufacturer includes the assembler and importer. Manufacturers of laser light shows that use Class IIIb or IV (3B or 4) LaserWorld demonstration laser products are also in violation of the Act.”
    It doesnt get too much clearer than that. I think now I am going to request this for every Chinese manufacturer also that states that their products are "FDA APPROVED!" I am SICK AND TIRED of having to bust my ass and go through RIDICULOUS amounts of paperwork and education and licensing and form submissions to be undercut and underpriced for equipment by people who feel that they do not need to follow any rules or regulations.

    There is a difference between people who attempt to do the right thing and are stuck because of slow response times of governing agencies. And those people that just dont care and do what they want anyway and just say, "Fu*k the rules."

    Sorry, i've just about had enough of losing business to foreign companies that just dont give a shit. I would rather go bankrupt losing ALL of my business to a USA based company doing the right thing than lose another $100 to a foreign based "illegal" company!!

    --Rant over!--

    -Marc
    http://www.laserist.org/images/ildalogos/ILDA-logo_colored-beams_Corporate_150w.jpg

    ILDA- U.S. Laser Regulatory Committee

    Authorized Dealer for:

    • Pangolin Laser Software and Hardware
    • KVANT Laser Modules & Laser Systems
    • X-Laser USA
    • CNI Lasers
    • Cambridge Technology & Eye Magic Professional Scanning Systems

    FDA/CDRH Certified Professional LuminanceRGB Laser Light Show Systems


  2. #2
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    Default

    I agree with you totally. I have been trying to push this for years.

  3. #3
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    Default

    good luck with that, I gave up on making any money with lasers

  4. #4
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    Default

    Sounds more like your issue is with the FDA and the lack of control they appear to have currently over the foreign import market and illegal show Co's.
    If it was properly controlled, you probably wouldn't find people had the option of even buying or using an illegal projector. But I understand that is changing currently anyway, so maybe the ball is coming back into your court.
    It does strike me that all of the regulations are currently only serving to hurt the domestic market however.
    Frikkin Lasers
    http://www.frikkinlasers.co.uk

    You are using Bonetti's defense against me, ah?

    I thought it fitting, considering the rocky terrain.

  5. #5
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    Jul 2011
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    Default

    Marc, I find your "rants" educational and informative. Don't stop these inclusive postings anytime soon.
    I do see a problem with what has been stated though.
    It boils down to how firmly or loosely the term "non-compliant" can be defined.
    I'm not opening the door to a discussion here about that but from a legal perspective I can see that term as the first target of opportunity for a defense of one of those, shall we say, less than honourable companies/businesses.

  6. #6
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    Default

    Hey "shorty"

    Sorry, my rants sometimes get the better of me and perhaps the educational or informative value may not outweigh the "PISSSSSED" value. lol, hopefully my above rant sufficed for more informative.

    In my opinion and the opinion of the CDRH (as written bove), its pretty simple:

    If a product is non-compliant, i.e.- is not properly reported and/or "varianced," than that product can *NOT* be "LEGALLY" brought into commerce in the United States. Period!! If said product, under these conditions, is brought into commerce, than it is now considered "illegal."

    All of the semantics of, "welll....technically i can use it in my house...bla bla bla..." is also incorrect because if you purchased said product, than that is considered commerce and therefore, an illegal sale. If you purchased the product in pieces and assebled it yourself, now *that* would considered "ok." However, you would still need to report the product and variance appropriately before the laser leaves your house to perform un public.

    -Marc
    http://www.laserist.org/images/ildalogos/ILDA-logo_colored-beams_Corporate_150w.jpg

    ILDA- U.S. Laser Regulatory Committee

    Authorized Dealer for:

    • Pangolin Laser Software and Hardware
    • KVANT Laser Modules & Laser Systems
    • X-Laser USA
    • CNI Lasers
    • Cambridge Technology & Eye Magic Professional Scanning Systems

    FDA/CDRH Certified Professional LuminanceRGB Laser Light Show Systems


  7. #7
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    Brno, CZ / Povazska Bystrica, SK
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    Default

    unfortunately most of the buyers are short sighted and won't see beyond the pricing - eg. they don't see the added value
    even though i won't go into anything less than Kvant now, i'm afraid this is kind of don quijote situation here but still keep up the good work!

  8. #8
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    Default

    Quote Originally Posted by gottaluvlasers View Post
    Hey "shorty"

    Sorry, my rants sometimes get the better of me and perhaps the educational or informative value may not outweigh the "PISSSSSED" value. lol, hopefully my above rant sufficed for more informative.

    In my opinion and the opinion of the CDRH (as written bove), its pretty simple:

    If a product is non-compliant, i.e.- is not properly reported and/or "varianced," than that product can *NOT* be "LEGALLY" brought into commerce in the United States. Period!! If said product, under these conditions, is brought into commerce, than it is now considered "illegal."

    All of the semantics of, "welll....technically i can use it in my house...bla bla bla..." is also incorrect because if you purchased said product, than that is considered commerce and therefore, an illegal sale. If you purchased the product in pieces and assebled it yourself, now *that* would considered "ok." However, you would still need to report the product and variance appropriately before the laser leaves your house to perform un public.

    -Marc
    just tell them to buy the non-compliant stuff, show up a couple months later to see if its installed and call up your local CDRH guy to go tell them "what's what"

    if you're not going to make the money anyway, its at least amusing to watch them get busted and have to take everything down

  9. #9
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    Thumbs up Excellent-post, Fellow Infidel! ;)

    Quote Originally Posted by gottaluvlasers View Post
    ...This customer just would NOT "get it." ...and argued my fact that Laserworlds systems are NOT legal here in the USA.
    This is because LASERWORLD LIES and directly-misleads people, in-order to gain sales... Proof: http://www.laserworld.us/images/stor...ld-and-fda.jpg -vs- The FDA's clear-position on the 'approval-process' vs illegal sales / deliveries (which is made much-worse, when they are sales/deliveries of uncertified and/or unsafe shinola-boxes...) - from Laser Notice 51, (...re-posted for the benefit of newcomers...[my comments, bracketed]...)...

    Dealers and distributors of laser light show projectors must have approved laser light show variances to purchase equipment from projector manufacturers. [In this case, LW...] This requirement ensures that awareness of laser light show radiation safety and protection practices and regulatory requirements are transferred from one variance holder to the next.

    Additionally, we assume that dealers and distributors may need to demonstrate the capabilities of the laser light show projectors to customers during the course of sale. In doing so, dealers and distributors are manufacturing a laser light show, which requires a laser light show variance.

    Therefore, any dealer or distributor of laser light show projectors must submit the required reports and apply for a variance to purchase and sell laser light show projectors. Laser light show projectors shall not be purchased until that variance application is approved and the purchasing party provides the projector manufacturer the purchaser’s variance number and its effective date.

    ...What they say to potential-customers on that 'Information about showlasers and FDA' page *directly contradicts* what the FDA says, last para:

    Laser light show projectors shall not be purchased until that variance application is approved and the purchasing party provides the projector manufacturer the purchaser’s variance number and its effective date.

    ...Again, my 0.02 is: it would be 'one thing' if, once a purchaser submitted their Var-app, and GOT their acknowlegement-letter / Accession Number (...NOT an 'Approval' yet....) - but that was planning to use an ALREADY-CERTIFIED product, that the FDA acknowledges is APPROVED / CERTIFIED (ie: Mobolazer ML-10, etc, etc) - AND - *more importantly*, is SAFE (ie: doesn't spit out spurious x-Watt beams when turned on/off / connected to / unplugged-from DMX, etc, etc) - - that'd be 'one thing', imo....

    ...But, essentially, what LW does, is say '...No need to vorry about wezur or not our produkts are aktually certified, my frriend! ...Just give us ze kredit kard, and ve vill send zu ze box, and you vill be happy und shiney und lazering avay before ze day iz ovuh...Don't vorry about doz pesky FDA-rrumorz!...Zer iz alvayz zum zilly rrumors, yah?!...'



    More 'light' on the FDA's-position: http://www.accessdata.fda.gov/script...ineId=1&SfxId= ..and this has not 'changed' since this was published...

    ..What I don't get, is *how* CAN there-be a 'Woodale, IL facility' that stocks / drop-ships these shinola-boxes, w/O being raided / shut-down by the FDA... I mean, that's effectively an entire *factory*, pumping-forth illegal / unsafe boxes and hurting US-manufacturers / the barely-breathing laser show-industry economy... then-again, how silly of us to expect the Gov to actually enforce it's own-laws, to the benefit of its' citizens / Biz's that at least *try* to do it right...

    ...any PL-members up-in 'Woodale' with a gas-can and a box of matches?*

    *'just in-case': THAT'S A SATIRICAL JOKE, LW!!!! DON'T GO BURN YOUR OWN FACTORY DOWN AND COME BACK HERE AND TRY AND POINT FINGERS!!

    Quote Originally Posted by gottaluvlasers View Post
    --Rant over!--
    No!!! Not till they take that BS-page down, and/or finally get-legal, and be 'worthy-opponents'... Till-then, gloves, still-off!

    j
    Last edited by dsli_jon; 10-20-2011 at 02:51. Reason: link fix, more obnoxious accents... :)
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

  10. #10
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    well... i suppose it has already crossed your minds quite a few times, but since the US market has its own issues, why not make the world your marketplace and start exporting some lazors???

    given the right ammount of attention it can be a sustainable business, me thinks...
    "its called character briggs..."

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