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Thread: Chinese (or other low-cost) Lasers with FDA Variances

  1. #11
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    Ok, discussions: (Read them before you dismiss the sources the way you did just now before you knew who they were).
    http://www.photonlexicon.com/forums/...n-NES-emulator
    Brad, post 3:
    "You also better be certain you get your variance from the CDRH to approve your projector (they'll love your emission sticker) and approve your shows." Clearly aware of the show context being important, as well as the projector.
    buffo, post 10:
    "In the end it will probably come down to the attitude of the inspector, but technically if there is any commerce involved in the event (even indirect commerce that doesn't involve the laser staff), the commerce clause still applies and CDRH has jurisdiction." Plus plenty more where the emphasis is almost entirely on the context, the event.

    I did find these too though:
    http://www.photonlexicon.com/forums/...ance-questions
    gottaluvlasers, Post 2.
    http://www.photonlexicon.com/forums/...low-PL-Members
    buffo, Post 12.
    Those both mention two different types of variance so I take your point that ONE of them can be for the projector alone, but the moment you use it in public you need the other. the one that allows the intended context, and not only will a Chinese maker not file for that one on a US buyer's behalf, they can't.. My point was that the user should expect to take care of this.

    Many posts by people in the US have not made this multi-variance bit clear, and all I'm trying to do is learn from them. If you have an axe to grind, take it to everyone, not just me. As to not saying anything about the UK or EU on lasers, maybe you should! Show a bit of interest. I will likely never enter the US but at least I care enough to try to figure out how it works.

    And if you have anything more to say to me, keep it short. You talk to me of " 'Context' is a literary-device" while spinning out posts full of abstruse literary devices. You are more than willing to interpret my short post in the most negative way, and totally unwilling to cut any slack even where there might be any point properly made. Was Stiffler totally wrong to agree with any of it?! You blew up like a bomb with a hair trigger, spewing invective and spiralling out of control. You have a problem with me? If so it's about time you nailed your colours to the mast and spat it out, all of it. What exactly am I that it gets up your nose so bad?

  2. #12
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    Also I don't think X-laser will just sell you a projector with the Polaris system. I am pretty sure they only sell that to experienced persons that they train and confirm have the proper knowledge and experience before letting those projectors out the door. Good sense on their part if you ask me. Just because the projector has the proper safety gear doesn't mean you will use it properly without training and experience.

  3. #13
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    OK...

    Quote Originally Posted by The_Doctor View Post
    Ok, discussions:
    Nope, that's NOT the 'point'. The 'point is', this is not some 'campfire chat' with Bro's and a few pints of ale - This is a public forum - that Google, et al, internet-searches just love - that people go to for CORRECT ADVICE.., ie:

    Quote Originally Posted by wmodes View Post
    ..Are there Chinese (or other low-cost) lasers who have their FDA variances? If so, can you recommend a contact?
    ..Pretty-specific request for help, doncha think, Doc?? And, aside from your vacuous-of-help answer about 'it not being (mostly) about the projector', you also diverged accurate education with:

    Quote Originally Posted by The_Doctor View Post
    Chinese sellers may be unlikely to supply a variance because it's expensive for them to do, and they can't control the context their product will be used in, so all it means for them is extra work, forcing the price up and reducing their likely market. It's basically not in their interest to do this.
    ..and how, exactly, is this a HELP to Wes in finding a 'certified Chijector'? All you did was summarize that the ChOEMs DO, in fact, break the law.. Ya, we spotted that, Thanks.. However, it's really NO EXCUSE. They CAN and SHOULD be building-compliant / filing for certification, before selling, here.. Able, Neo-Neon, and a few others have done it - it's neither 'some horribly-prohibitive expense', nor all that difficult, just a bit time-consuming...

    ..Tell ya what. You wanna help 'educate' Wes? Please, first, educate yourself, here: http://www.fda.gov/MedicalDevices/De.../ucm094445.htm ..And You tell us / Wes - What are the ChOEMs supposed to be doing, before they offer their wares, for sale, here in the US? And, what else are they supposed to do / know, before they ship a pj, to someone, here? Hint: It's not at *all* 'expensive'.. THAT would have been something helpful to Wes, et al, to-post, relative to his questions.. And, I've given him several 'accurate info sources' for AS-considerations.. IF that was Your post? You'd've never heard from me..

    Quote Originally Posted by The_Doctor View Post
    ..Many posts by people in the US have not made this multi-variance bit clear, and all I'm trying to do is learn from them.
    That's great! Glad you are keen to learn.. So, try not to post unclear / errant advice to new-comers - here in the US, where you are not an expert on the Regs / nor do-shows - especially for something serious, like Audience Scanning.. until you - at least - are going to point people in the correct direction.. Disjointed-answers, like 'it isn't so much the projector..' can lead one to think 'Hmm, ok, so.. all I gotta do is find a ChiCo that sells "FDA approved" projectors, and I'm set!'.. Next thing you know, we have more of this ignorant-shyte.. http://epiclasers.com/laser-video ..in-particular, the *second* video.. Atrocious! ..and, this cad is *still* not Varianced / Registered in his State, etc.. (aka, ILLEGAL..) let-alone Varianced for AS / using an AS-approved system / techniques..

    ..So, here we have Wes showing exceptional-sensibility in asking for direction, *first*.. You did not deliver good-direction, here, but instead, diluted the issues, (unintentionally, I am not accusing 'malevolence'..) and gave no-real helpful info for his question..

    Quote Originally Posted by The_Doctor View Post
    If you have an axe to grind, take it to everyone, not just me...As to not saying anything about the UK or EU on lasers, maybe you should! Show a bit of interest.
    Please see who first-populated the 'Safety Wiki', here in PL. http://www.photonlexicon.com/wiki/in...itle=Main_Page Oh, including (at the time, at least..) correct Links to the EU / UK Regs that could be found.. Even-so, you'll never see me posting 'advice' in some thread about EU / UK-Regs, when I've got no more than the 'cursory' understanding available to everyone.. I've got *no* business advising someone there, when I've no-direct experience, filing there..

    Quote Originally Posted by The_Doctor View Post
    ..at least I care enough to try to figure out how it works.
    Great! So *ask questions*. Don't dole out advice when you don't know enough about what you're advising.

    Quote Originally Posted by The_Doctor View Post
    Was Stiffler totally wrong to agree with any of it?!
    Nope, in fact, Erics' posts were a margin more helpful..

    Quote Originally Posted by The_Doctor View Post
    ...What exactly am I that it gets up your nose so bad?
    Again - Sorry, but Yes, I am saying 'unless you're truly-qualified' (educated and/or experienced..) to post-advice on US-Regs - especially for AS.. Please don't. And PS - 'where there's no wood, the fire goes out' - I would not have 'blown this up', if you'd simply have 'nodded to the first ear-tug', k? Questions / clarifying-discussions are always welcome.

    PS - +1 to what 'drm916' said.. It's more than just 'good sense', it's 'the Law'.. http://www.fda.gov/MedicalDevices/De.../ucm094445.htm

    j
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

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    Thanks Jon for spending the time to cut through this. I couldn't agree more.

    I would like to step back, if I might, to the OP. In my opinion (OPINION), audience scanning requires a fair amount savvy. The equipment must be right, the operator must know what he is doing and the paperwork must be complete. For someone with only a couple of months of experience to leap to this level is pretty tough and I think he should be encouraged to start doing safe shows and move to this feature in stages. I suspect the process will seem less daunting and he can get some more immediate gratification as he figures this out.

  5. #15
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    So we have a consensus that the laser operator has to find out what to do, and do it, so even if there is a variance provided for a projector, there is no basis for not understanding what is happening well enough for the operator to do it themselves. They'll have to file their own show variance anyway. Buffo in another thread said it's not very hard to do either.

    Any info I got came from people here who apparently do know what they're doing. I cited posts that show that while some are clear, many others are as casuall and potentially confusing as anything I have said, and that explains a lot of my own difficulty in picking it up. Either this place is useful for shared advice and information or it isn't! If there is a chain of Chinese whispers, don't 'fix' just one link. I'm usually persistent enough to fix an error in myself when I discover it, so Jon, you'd best start dealing with those that seem to be unaware of their part in this chain of vague information if you want to continue a crusade.

  6. #16
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    Quote Originally Posted by The_Doctor View Post
    So we have a consensus that the laser operator has to find out what to do, and do it, so even if there is a variance provided for a projector, there is no basis for not understanding what is happening well enough for the operator to do it themselves. They'll have to file their own show variance anyway. Buffo in another thread said it's not very hard to do either.

    Any info I got came from people here who apparently do know what they're doing. I cited posts that show that while some are clear, many others are as casuall and potentially confusing as anything I have said, and that explains a lot of my own difficulty in picking it up. Either this place is useful for shared advice and information or it isn't! If there is a chain of Chinese whispers, don't 'fix' just one link. I'm usually persistent enough to fix an error in myself when I discover it, so Jon, you'd best start dealing with those that seem to be unaware of their part in this chain of vague information if you want to continue a crusade.

    Doctor,

    You know, all you readily do is regurgitate what you have read over the past ten years or so. Its time for you to give it a break and go out and do some actual lasing. When one has publically admitted they sold their last scan set, its not a good idea to wax philosophical with the careers, equipment, and safety of others.

    Kudos on having the brain power to collimate information in the way you do, but your ASCII database of laser newsgroup and forum text is slipping out of date. Perhaps to post in a thoughtful, meaningful, manner in a few threads rather then commenting in EVERY thread would be a good start.

    This is not the elegant essay forum, this is a place for applied, practical, knowledge and fun.

    Commenting on safety practices when you are not engaged in doing or learning of such practices is crossing the line.

    Perhaps you should go out and do some volunteer work, some place where that memory skill is useful. Get out and meet people instead of dwelling on PL all day.

    There is no way for me to say this without coming across as cruel, but there IS life outside of PL.

    Steve
    Last edited by mixedgas; 02-24-2014 at 18:50.
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  7. #17
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    Quote Originally Posted by The_Doctor View Post
    So we have a consensus...
    No, Sir.. it's called a Federal Code Block.

    Quote Originally Posted by The_Doctor View Post
    ...so Jon, you'd best start dealing with those that seem to be unaware of their part in this chain of vague information if you want to continue a crusade.
    I created.. well, 'first-populated', the Wiki.. I'm pretty-sure that 'counts', ya? and I direct everyone I possibly can to the best info / help, where I can.. Can't help everyone, all the time... IF this was 'my place', as I've posted elsewhere, I'd obligate every-new signer-upper to at least 'pass thru' the Wiki - so they knew it was there - and, even if they didn't read, (as was correctly pointed out, in those other threads, et.. 'You can lead a horse to water, but...' etc, etc..) right-then, at least they'd a) know there ARE Regs / safety-considerations, and b) again, they'd know we had a local-resource...

    ..but, I obviously don't 'own this place', and that's quite a good thing.. I'd prolly end-up 'snipered at some gas-station'...

    Anyhoo, I've said everything I felt needed to-be said; Wes has the links / info he needs.. No need to 'take this personal', Doc.. You'll notice I have nothing to say in your 'other threads'.. this was / is NOT 'about you'... it's simply about doing what CAN be done, to water the seeds of accurate-education... And, btw, that *includes* me.. I've 'stood corrected', plenty of times, and I will yet, many, many, many more.. And - I can only hope. The day we stop being willing to be taught / learning, is the day we start rotting and dying.

    ..so with that, I bid you good reading and a couple of kwaks..



    L8r..
    j
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

  8. #18
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    Quote Originally Posted by Stiffler View Post
    Hi Wes,

    As the Doctor stated, a lot of the cost is with the variance process itself and as far as I know NO Chinese company, and very few non-US companies offer lasers with any variance, much less a variance for crowd scanning. X-Laser is going to be your most economical option, but you will still probably need to spend $5000-10,000 for a projector you can audience scan with, plus the extra paperwork for your variance. And that is on the cheap end.
    Just a quick warning - there are 2 companies called X-Laser: X-Laser in China and X-Laser USA.

    They are not related.

    I believe only the USA X_Laser produces varianced projectors so be very wary of cheap X-Laser products advertised on the internet as you might not be getting the varianced USA product.

  9. #19
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    Just a quick warning - there are 2 companies called X-Laser: X-Laser in China and X-Laser USA.

    They are not related.

    I believe only the USA X_Laser produces varianced projectors so be very wary of cheap X-Laser products advertised on the internet as you might not be getting the varianced USA product.
    Covered in point 4 of post #6, but Jon's style makes it a little awkward to fathom (he's been 'told' but he's just bloody defiant!)
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    I thought it fitting, considering the rocky terrain.

  10. #20
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    Sorry I didn't read Jon's posts, just gave them a quick glance, as I do find them very hard work to read.

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