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Thread: Seller's product certification requests?

  1. #11
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    Yea, I kind of went off into right field and did not give you the credit which I genuinely think you deserve for proposing something like this. I think it is a great idea.

    As for your question, I hate to say that I don't know but I have never really fully understood the precise relationship between docket numbers and accession numbers. My cursory understanding is that they are one in the same, or at least serve the same basic function. I am though open to being corrected on that.

    The bottom line is that most foreign sellers are not going to get into compliance and even if they do they are not going to stay in compliance. It is too much work and much too expensive. US compliance adds, on average, 40% to the cost of the projector for us and it is sometimes as high as 200%. Very seldom do people want to take on that level of expense when others will just ignore it and take their sales.

    As for what to do with an illegal projector... that is tough one. I'll tell you what I did: My very first unit was illegal and as soon as I discovered knew better I threw it off of the back of our loading dock.

    In any case, kudos. Let me know if I can help.

  2. #12
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    Quote Originally Posted by allthatwhichis View Post
    My purpose for this thread is to discuss if we should, as a community, work with potential full projector sellers posting here to get them to certify their projectors before anyone here commits to purchasing one...
    Dan's oh-so right - it's an 'ant hollering at a fright-train to STOP'.... But, if, as you are excellently-encouraging, if - at the *very least* - when new 'OEM's post to PL, selling their wares, we, as a community, say: (nicely) "Please supply us (along with your 'amaZing prices'...) how your product is compliant...blee, blah, blah, etc.."

    ...at least that spurs USA PL'ers to 'think before they plunk' (-down their cash...) and others, in the EU / beyond, to at-least *consider* safety over 'cheapness'... Then, all that 'steering-peeps away from the dark-side' gets cached, and PL, as a whole, has a nice 'high-road / CYA'-aspect to it... I mean, heck, we've even got a growing 'SafetyWiki', here, woohoo!

    Quote Originally Posted by allthatwhichis View Post
    a docket number one step further back? You get a docket number before you get an assension number?
    CORRECTION: The 'Docket number' / letter, is like a 'return-receipt', acknowledging receipt, and entrance into 'the line' (...like 'take a number', in line at the meat-counter...) - it is what you 'first get', from them...The 'Accession number' is issued when they 'officially submit it', internally, for entrance into 'the-process' / review, etc, which gets filed in the Federal Register / FDA DB for referral-to / amending comms-about, later, whether approved or not... This number 'changes', as there are 'communications' between you / FDA, in subsequent-years (...petitions for renewals / amendments, etc) ...

    ...But again, at the *most*, getting that-far into the 'process', is like 'submitting an-app for auto-credit' - does *not* mean you are, or-will get any sort of approval / you can just 'walk off the lot with the car-keys'... So, sellers saying 'all you need to do is send in the paperwork, and you can take delivery on our lazor-box', is really (...according to Laser Notice 51...just 'citing the source', yet-again..), contradictory to current FDA-policy...

    IF it's a genuinely certified-system, well, that, (to me, personally - FDA *still* says end-user Var. must be in-place before shipping...) would be 'one thing' -
    But shipping an *un-certified* / unsafe box, and before the customer has their Var. approval...that's really a double-asking for trouble-whammy...

    ...'Ant yelling at the train'... But we can *try*, yes? Good call, Aaron...

    j
    Last edited by dsli_jon; 05-30-2011 at 02:00. Reason: corrected correction...
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

  3. #13
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    The sad part is even if PL users standardized a design, sourced parts, made it compliant, offered it as a kit, etc. We could still not make the process easier or faster.

    Why? Because it is the manufacturer who does the quality control and is held responsible. While this is a great safety scheme for medical devices, in the modern laser show "disposable" box world, it does not fit the world model. He/She who assembles the device IS the manufacturer, under the law I probably can't sell you a kit* or a partial kit, without the device coming back to me for inspection.

    Since there is no alternative of using a standardized design and having the end user do a checklist, the best PL can do for US laserists is to ask sellers of commercial products to show us something more then a accession number, what that may be, I do not know. I suspect the letter from FDA stating approval of a manufacturing report might be a start.

    Now where are you going to differentiate what a commercial sale is? Two identical units? If someone sells one 19,000$ RGB a year, are they a manufacturer in the eyes of PL? Is it sales volume or sales gross that makes you a manufacturer?

    Tough problem, but perhaps PL users should ask about compliance as a means of educating the sellers. Even if it has no teeth and is a gesture at best.


    *Low power hene kits have been sold, the legal premise being a .1 mW short hene tube (bar code tube) cannot physically change enough to reach powers above say .15 mW. I own a ETS-4200 hene kit from Heathkit. The tube is from 1987 and still runs. I'll read the documentation some day and see what the catch was.

    Steve
    Last edited by mixedgas; 05-29-2011 at 05:31.

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    additionally I am willing to bet the reason KVant has not made compliant projectors is because they probably sell 1 out of every 1000+ projectors to the US... the US is just not a major market for lasers/laser shows...

    not like everywhere else (europe/south america/etc) where every night club is trying to give everyone who is photosensitive a seizure lol

  5. #15
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    Quote Originally Posted by flecom View Post
    additionally I am willing to bet the reason KVant has not made compliant projectors is because they probably sell 1 out of every 1000+ projectors to the US... the US is just not a major market for lasers/laser shows...
    True, but, Flip: I'd bet that they could (potentially) sell more, if they simply took the time to work with a States-side Importer (that has a clue... and get them certified - they're not all that 'far-off' - They've already got: proper-type keysw., laser-compartment door interlocks, emission-delay, and no 'dangerous tie-ins' to silly DMX-activated 'demo-boards' that tend to spit out a beam when you shut the thing off...

    ..I'd only see them needing: Emission indicator near output window + hard beam-shutter, both tied to emission-delay and interlock circuit, ensuring the interlock circuit is properly tied-into the ILDA I/O, etc, and proper US-labelling... It's really *not* all THAT hard to make a projector compliant, nor is the Product Report all that 'brutal' - the real 'PITA' is the arduous process with the FDA, because it's a ghost-town, now... But, even-so, it's really not all THAT hard, and in-theory, Kv's would then-be more attractive for pros in the biz, who have to worry about liability, etc...

    ie: I've heard that RGB Hungary, is certainly 'glad' they worked with LSDI / Greg M. to get the Compact-line up to par, for this very-reason (more US sales...) -
    Now, LSDI, are the ones that actually *certified* them with FDA / are the Importer / 'manufacturer' of Record, but they put the onus on RGB to make them 'compliant' before they ever landed... Very smart way to do it, cause then, he's not having to re-work thier boxes, etc - He simply gave them a 'checklist' / worked with them on the CADs, etc, and - they did it... Result? They are probably the best-selling *legal* import, (in their 'class'), as a result... And man, are they nice. (imho..

    peace-out...
    j
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

  6. #16
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    Few things-

    1) Aaron. AWESOME idea. bottom line to this idea is plain and simple. there are TONS of manufacturers and projector makers who pop up here quite often. when they advertise their product(s) they are advertising and promoting it to a world market. for the U.S. PL members on this forum we should immediately ask them their credentials. I will tell you now, and this is from the horses (CDRH) mouth- there is only TWO (2) foreign laser manufacturers with valid VARIANCES and CERTIFIED products in the U.S. they are RGB LAser Systems and Arctos. there is not, never has been, never will be (i would bet my left nut) a chinese laser projector manufactuer with a CERTIFIED Laser projector system.

    Accession # is as useful as my dogs license number on their collars. it means NOTHING!

    I am honestly thinking of performing an experiment. I am going to send in a BLANK product report tomorow and withing 2 weeks i will get an acknowledgement letter back with an accession number in it. as dan and jon stated all an accession # is is a filing number saying, hey- thanks for sending us some mail. here is your confirmation number that we opened your mail.

    2) my understanding after some very recent turmoil is this:

    Accession # is (as stated previously) simply a number to track your submission with the FDA/CDRH. it provides NO informaiton as to its approval or certified status.

    Once a submission is officially entered into "non rule making" status with the FDA (non rule making because any decision made by the FDA on your submissions does not affect any official "rules" or regulations. It is "varying" (hence- variance) from those rules.) sorry- once your submission officially makes it to this point it recives a docket number. Once a docket number is assigned it is now officially being "looked over" and is officially being considered for approval. it IS NOT an approval or denial. it is simply your docket number for this specific request for approval.

    just like if you go to court. lets say you sue someone. when you file the paperwork, you will immediately get a case number. this case number (accession #) does not provide ANY outcome informaiton or prove guilt or non guilt. it is simply your identifier. once the case makes it to the judge, and lawyers get involved and court date gets set- NOW you get your docket number. this is the offcial number identifying your specific case and your specific requests, compaints and suits.

    the docket nuber which is assigned to you from the CDRH is the number that will become your variance number. NOT the accession #. the docket number identifies your specific requests, applications, decision status(s) and documents.

    3) KVANT Laser systems WILL BE U.S. certified properly and has already begun. I am *not* the one doing it. but the official reporter and perosn doing the certifying is more than capable of it. he prob has more experience than all of us here combined. So, this will not be a problem.

    -Marc
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  7. #17
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    Default Aaron - your idea has already *worked*... :)

    Quote Originally Posted by GT500 View Post
    I went with Kvant... don't want anything to do with LW
    Yaaay! yet again, to your suggestion...

    Yo Marco -

    Quote Originally Posted by gottaluvlasers View Post
    ...once your submission officially makes it to this point it recives a docket number. ...just like if you go to court.
    Actually, I thought had remembered it exactly sdrawkcab.....buuut, I didn't...

    The 'Docket number' / letter, is like a 'return-receipt', acknowledging receipt, and entrance into 'the line' (...like 'take a number', in line at the meat-counter...) -
    it is what you 'first get', from them... See HERE for an 'example'...

    The 'Accession number' is then-issued when they 'officially submit it', internally, for entrance into 'the-process' / review, etc, which also gets filed in the Federal Register / FDA DB for referral-to / amending comms-about, later, whether approved or not... This number 'changes', as there are 'communications' between you / FDA, in subsequent-years (...petitions for renewals / amendments / annual-reports, etc)... Interestingly, this def is pretty spot-on: http://www.businessdictionary.com/de...on-number.html

    But, again, your 'point' was-correct - as has been re-iterated to-death, here ..it *ain't* any sort of 'approval' / 'certification', and it's a super-shady (and illegal) way for these overseas Co's to be racking-up sales...

    Quote Originally Posted by gottaluvlasers View Post
    ...there is only TWO (2) foreign laser manufacturers with valid VARIANCES and CERTIFIED products in the U.S. they are RGB Laser Systems and Arctos.
    Just a 'mild correction', as recently as last-month, there was a little 'fracass' over the RGB Compact-line - reason-being, the Client whom we helped get their var-processed, actually put "RGB Lasersystems Compact 2 / 4 / 8" in their App. and the, uh, 'CDRH 'guy' would not approve their inclusion, because he said he 'couldn't find them in the DB'...

    So, I said, 'well, shoot'... (although the 'officer' should have been astute-enough to find all the projector-info via the *actual* Importer of record / Certifier's (LSDI) Variance#s, but he "could not"...) ...'please 're-check', listing "LSDI" as the 'manuf', and 'RGB_XXX', etc, etc as the projector, and 'voila', he found them / the info...

    Point-is, although - Yes - those Projectors *are* compliant / certified, it is 'thru' LSDI's Var., not RGB-directly, so, anyone wishing to 'add' those systems to their Var. (for, ie: 'x-rentals', etc) you would not want to list those projectors as "RGB Lasersystems"... Here's the LINK... just an 'fyi'...

    Quote Originally Posted by gottaluvlasers View Post
    KVANT Laser systems WILL BE U.S. certified properly and has already begun. I am *not* the one doing it.
    Just 'for the record', when I said:

    Quote Originally Posted by dsli_jon View Post
    ...if they simply took the time to work with a States-side Importer (that has a clue...) and get them certified...
    ..I was *not* referring to You, just so ya know... I was simply speaking about *anyone* doing that (working with a foreign-OEM to get compliant), States-side, would, yeah, best-be someone 'with a clue' / experience... Which, I know, you have... 'you have done well, Grasshopper'... Just so'z I wasn't 'misunderstood'...
    I'd hate to get the 'Prick of the Week Award'...again...

    peas..
    j
    Last edited by dsli_jon; 05-30-2011 at 02:16. Reason: correction...
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

  8. #18
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    My wording was wrong from my earlier post - my intent was to clarify that even the foreign projector manufactuers that have varianced product in the US, did not do the legwork/paperwork for this, as Jon has clarified, they worked with a US manufacturer to get to this stage.

    LaserNet/Neo-Laser. The Trinity Pro/Semi-Pro and Matrix laser projectors are Chinese and US varianced based on what I have been told by LaserNet. I've also been told by Jim Hardaway, who consulted for Neo-Laser, that versions of these systems are US compliant as they ship from China.

    I'm not defending non-compliant products, nor am I wanting to perpetuate any arguments here, I just wanted to point out that none of these manufactuers would have approved products in the US today, if someone in the US didn't import these products and work with the foreign manufacturer to make them compliant, ultimately allowing for a varianced product.

    Greg
    Last edited by Displaser; 05-30-2011 at 11:35.
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    Quote Originally Posted by Displaser View Post
    ...I just wanted to point out that none of these manufactuers would have approved products in the US today, if someone in the US didn't import these products and work with the foreign manufacturer to make them compliant, ultimately allowing for a varianced product.
    This suggests a manufacturer outside the US could not apply for a Manufacturer's Variance. Is this true?

  10. #20
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    Quote Originally Posted by taggalucci View Post
    This suggests a manufacturer outside the US could not apply for a Manufacturer's Variance. Is this true?
    To the best of my knowledge, these foreign manufacturers could do all approvals and obtain a variance for the US, but as our recent wave of "advertisers" have stated, "they don't have to".

    It would appear that the responsibility falls onto the importer/US manufacturer/end-user to abide by the law.
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