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Thread: Seller's product certification requests?

  1. #1
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    Laser Warning Seller's product certification requests?

    I have been thinking since "el gringo loco's" post last night that we here on the forum may want to start holding laser projector sellers to the same standards we are held to by the fed. By laser projector sellers I mean professional sellers; not buying a DIY projector from a fellow forum member. If a seller posts they sell projectors, we hold them to providing the needed documentation from the CDRH before we agree to buy any full projector from them. I know there are a few that request this once a seller posts a thread indicating they sell full projectors; my thought is we need to come together as a forum and ALL do it.

    Thoughts?
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    allthat... aka: aaron@pangolin

  2. #2
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    Irrelevant for a good percentage of the population of the forum.

    I think it would be unfair for PL to restrict sales of projectors without CDRH compliance as this would stop users outside of the US being able to benefit.
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  3. #3
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    Most foreign projector manufacturers (compliant or not) are going to expect either the importer or end-user to do the heavy lifting on this. To the best of my knowledge, even those that make a compliant projector do not have accession numbers.

    Example:

    RGBLasersystem - compliant mfg., Importer holds accession number
    KVANT - not compliant (last time I checked, may have changed?)
    Neo-Laser - compliant mfg., Importer holds the accession number
    Others?

    Compliant with an accession number likely prices this out of the reach for most on PL.

    Is there a means to legally import a non-compliant projector into the US if the proper documents/steps are taken to ensure compliance after arrival, before placing the product into commerce?
    Last edited by Displaser; 05-26-2011 at 14:36.
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  4. #4
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    Perhaps a list of compliant vendors for those in the US. Then, anyone who needs to buy from a reputable and compliant seller knows where to go and may save them a bit of a headache.
    Those who fail to grasp art are the ones who criticize it.

  5. #5
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    Lightbulb 'el gringo' speako.. :)

    Quote Originally Posted by norty303 View Post
    I think it would be unfair for PL to restrict sales of projectors without CDRH compliance as this would stop users outside of the US being able to benefit.
    I don't think he was proposing 'restriction', simply that it is good for *all* (not just US PL-members) to put these 'CHOEMs' (...and any other Countries, for that matter...) to the 'test' -

    ie: Please supply us (along with your 'amaZing prices'...) proof your product is compliant with EU / IEC safety-regs, (and/or FDA Regs, if being-offered for-sale in the US...)

    ..I (for one) think this is great advice from allthat, - for everyone, here - since we've seen examples / heard first-hand reports of how, for example, (some) LW-products are not even-compliant in their own homeland, which is pretty-succky to find-out, post-'they-gotz-yer-money', when you go to register it with the Guv, and they 'bounce it'...

    Sure, if a potential buyer does not 'do his / her homework', pre-purchase, well, then that's sort of their 'own fault'... But if, at least the PL community were to 'pressure' - or even require - that those who wish to peddle their wares, here, *also * provide proof that their gear is, indeed, compliant (with the applicable-reg body), so post-sale paperwork, etc, won't be a headache, and, more-importantly, ACTUALLY SAFE... (ie: doesn't spit out a spurious full-power beam when you turn on / off / connect DMX, etc, etc...)

    Quote Originally Posted by Displaser View Post
    Is there a means to legally import a non-compliant projector into the US if the proper documents/steps are taken to ensure compliance after arrival, before placing the product into commerce?
    Typically, the best-way would be to work directly with the overseas OEM / ask for CAD-drawings / schems from the potential-manufacturer, and then, *you* do the States-side Product Report / get it Certified... IF there are 'deficiencies' (ie: LSDI going back to RGB and having-them integrate a hard beam-shutter, with delay, tied to the interlock-circuit, etc - before they submitted to FDA for certification, etc..) then you work with the OEM to get those corrected', before they ever land on US soil, for sale...

    Of course, you can work with the FDA to get something 'brought-in' on 'temporary import-bond', etc, while you work thru this process, etc, (see attached 'RADEC', below..) but you can't (legally) go selling those / doing shows, etc, till they're actually compliant / approved... Course, you need have your own 'Show-Producer Variance', so the FDA will 'feel comfy' that you, in-turn, know / will-follow the Regs, etc...

    Yeah, sux to have to wait / take the arduous 'high road', but in the long-run, it's the best-way to 'CYA'...

    Hope this helps...

    Dan?
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    Attached Thumbnails Attached Thumbnails RADEC.pdf  

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  6. #6
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    Thanks Jon.... I remember seeing that document some years ago when I was considering purchase of a Neo-Laser system located in Europe, but the purchase fell through.

    Greg
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    Not sure if i'm following this to aaron's intent, sorry long day, but do you want to start getting "firm orders" in the works then make sure the mfg provides the correct paperwork?

    Maybe some of these "high end" systems being sold as FDA varianced could face some expensive visa/mastercard chargebacks since they are not compliant in the US. Visa don't want their cards being used to break Federal law, do they?

  8. #8
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    Lightbulb

    My thought was simple and mainly to start a discussion. Yes each country is different and my communicaed thoughts are only from my country's perspective; each member should look at this from their own country's laws. Mine just happens to have the strictest laws...

    If company XYZ laser projector company wants to post a for sale thread here, we as a community and before any member agrees to buy one of their projectors, demand they prove their product is compliant with what ever country's regulations a possible buyer is from AND be certified in that country. It is actually illegal for any of us in the US to import a non-certified projector and I think it is our responsibility to not only keep ourselves legal, but to keep our self moderated forum free of thread that would possibly cause us to break our own import laws because a projector company is not compliant.

    Again, this is only for full projectors; OEM laser manufactures like Laserwave and Ultralasers can post for sale threads all they want as OEM products need not be compliant for import, as far as I know. To me this is mainly to keep us and the forum on the correct side of the law. This would actually impact few members as most here are building their own projectors for personal use.

    And to re-state, i just thought to open a discussion. I hate to see one or two members pushing this with little success.

  9. #9
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    Guys -

    I am going to jump in real fast to clear up something here:

    An accession number means absolutely nothing in the grand scheme of things. For the purposes of this discussion, it is totally meaningless.

    An accession number is a file number in the FDA system that allows you to reference the 'location' of your correspondence when you contact them. Any variance app, product report, etc. gets an accession number. That does not mean that the report is satisfactory, or even complete, or anything other than a greeting card... it is a file number and nothing more.

    Where this gets confusing is that manufacturers ARE allowed to import laser products (having been properly product reported) for testing, R&D, etc. using an accession number. But, they are not allowed to sell them. Also, no one "holds" an accession number... it attaches to paperwork filed by an entity. That's all.

    Step one is making a product compliant whether here or somewhere else.

    Step two is filing the paperwork attesting to compliance.

    Step three is having the paperwork approved.

    Step four is being able to sell.

    An accession number does not even reach step three. It is illegal to import a radiation emitting product from overseas unless that product is a) properly product reported, b) the manufacturer of record has an approved variance to introduce product into the US for sale, c) the manufacturer maintains a robust QA program with written records demonstrating ongoing compliance, d) the manufacturer designates a state side entity to handle correspondence, warranty repairs, etc. and trains the personnel at that firm to including or above the level required for an LSO who must also then have a variance to handle the product, e) etc., etc.,.

    I am really trying not to get onto a high horse here and God knows that I have no interest here in selling product because the stuff we make is not really useful for you guys, but I am constantly amazed at how readily people will post that they have purchased, imported and/or manufactured uncertified, and/or otherwise illegal laser products on a public forum indexed by google.

    You having a variance is great. it does not mean that you can legally buy whatever you want and tinker with it. Certainly the FDA has better uses of their time than raiding the homes of hobbyists who undertake laser oriented projects... but I think that people need to at least understand the liability in doing it. Having an accession number to wave around is about as useful as waving around a driver's ed handbook when you get pulled over while driving a vehicle without functioning taillights. And now, I step down from my horse and await the shellacking. =)

    PS: There is no such thing as a "compliant manufacturer." Manufacturers can make a product that is compliant with one standard, and non-compliant with another. What matters is how well the product meets or exceeds the applicable performance standard and that varies by model and even by unit.

  10. #10
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    Lightbulb

    Thanks for the clarification although this may go beyond the scope of my hope for this discussion. No shellacking here, but since you brought it up, I am not sure many of us who have bought an uncertified projector from another country even knew it was illegal when we did it. I know I didn't until the safety meeting after last year's SELEM over a year later. What are we supposed to do after the fact, send it back?

    I am currently working to get my DIY projector certified and varienced; have spoken to Dan over the phone and twice through email, although Woody or Dale would eb the person looking at my documentation mailed yesterday... and today. (didn't realize the application goes to Fisher road and the report goes to New Hampshire Avenue) I reproduced all the safety features in my imported projector so it can be certified and varienced also; even if I have to send an ademdum back due to a slightly different beam path in area "A". I have done a full rebuild and consider myself the manufacture now but that doesn't change the fact of how I got it.

    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 and, in the US atleast, importing them wrongly. Sicne these are Google cached, it would look good if we are trying to make projector importers compliant to something. I figure if they are compliant to the US regulations that would fit the bill for most other countries.

    And since you have clarified assension number... is a docket number one step further back? You get a docket number before you get an assension number?

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