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Thread: X-Laser's New Variance Process

  1. #11
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    You are right that "should" is an important word; but it is not a marketing word as you say. There are functional mechanisms within the FDA that we have no control over such as the speed of their intra-agency mail system, how documents are delivered to the appropriate parties and how then that party generates a letter... The FDA is working on that but I chose the word "should" instead of "will" simply because I did not want to overstate the case. I have taken great pains to be accurate with this announcement.

    That having been said what is more important is how CDRH treats and views the submissions irrespective of how they are moved around within their complex system. That is what this announcement was about.

    On your second point, this is not a situation where I talked to some guy and he said OK and I am going from that... That would be patently insane. This was a formal proposal which resulted in a formal amendment to our manufacturer's variance which is of course in writing as accepting our new process. I have the paperwork in hand and made sure to before I said a word about it.

    But to just make this up or even embellish it would make us lose credibility with this community, with the market, and the industry. At that point it would be nothing more than an attention getting device and I have more than enough actual work to do. =)

    Adam Burns is under our NDA so if he is so inclined to be arbiter again, not to put you on the spot Adam (sorry!), I will happily show the approvals to him and he can report back.

    And since you raise the question of what is in it for you guys, I would think that faster variance approvals and the possibility of a vastly streamlined system down the road would both be good. In any case, it is progress and as I say above, I am happy to put the paper where my mouth is.. so to speak.

  2. #12
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    Smile Since Dan is relatively new to PL, please allow me to vouch for his integrity...

    I've been to X-laser's facility for an extensive tour back in May, and I was informed about this new variance program that they were developing back then. I signed an NDA stating that I could not reveal the substance of the technology behind their system, but I can say that given what I know about how it works, I can understand why the CDRH signed off on it. See my detailed review for more info about this tour.

    Also, on a more direct level, let me state for the record I've grown to trust Dan implicitly over the past half-year or so. The guy is a straight shooter, and he doesn't make claims that he can't back up. Unfortunately, he's also competing with several other companies (mostly non-US suppliers of cheap laser product) who would like nothing better than to copy his business model and cut his legs out from under him. So he has to be cagey about what he talks about. He's not kidding when he talks about the huge amount of time and money he's poured into his business, and into this streamlined variance program as well. He needs to protect that investment if his business is to survive. This is not a second job for Dan, this is his livelihood we're talking about.

    What I'm saying here is, don't misinterpret his reluctance to "show you his cards" as any sort of intent to be deceptive here. Because I *have* seen Dan's cards, when I toured his facility. All of them. I was given unprecedented access to his records, his communications, even his business plan. So I can vouch for the fact that this is not a bunch of smoke and mirrors (no pun intended), even if I can't divulge any details because of the NDA. (If Dan were to post certain communications from the CDRH, it would give away enough information about his new program that other competitors could easily duplicate the methods and safeguards he's come up with.)

    If you still have your doubts, then go to one of the "professional" guitar center retail outlets and ask them about buying an X-laser brand laser projector. You'll be able to learn a bit more about the new streamlined variance process, though still not enough to copy it for your own business use. (Note that this might be a viable option for some hobbyists with a little extra cash who would like to speed up the variance process, rather building your own projector and then filing the paperwork yourself.)

    Note also that several other large laser companies have been developing their own ways to work with the CDRH and their chronically slow approval process. So the concept in general really isn't a new idea. Every company has had to work with this issue, and some have been more innovative than others in coming up with solutions. (And yes, many companies blatantly ignore the rules and hope they don't get caught, but that's another story.)

    The point is, X-laser has come up with a *unique* solution that is far superior (and much more streamlined) than anything else I'm aware of. So don't hate on them because of their ingenuity. They just came up with a great idea (first), and went through the considerable effort to get it approved. Other companies may well end up following their lead at some point, but I'm sure Dan is hoping to gain a greater foothold in the market first, by leveraging this new variance process as a big selling point.

    For those of you who were at SELEM this year and had a chance to speak to Dan in person, I think you understand where I'm coming from. For those of you who have never met Dan, I can understand your skepticism. But remember that I was equally skeptical of Dan, and of X-laser's early claims about projector power. As it turns out, my skepticism was unfounded, and I have apologized, both in public and in private, for my initial accusations of Dan and his business.

    But I will say now that I can confirm everything that Dan posted above as being legitimate and legal, and you can take that to the bank. Were I in the retail market for a laser projector, and especially if I didn't have a variance, I would definitely consider buying an X-laser projector.

    And if you are still skeptical, then do what I did: Drive to Washington DC, sign a non-disclosure agreement, and then sit down with Dan and his father and start asking questions about their business. I think after a few hours, you'll be satisfied that their on-the-level. (OK, admittedly I spend more than just a few hours, but I wanted to be thorough.)

    Adam

  3. #13
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    For the record. I am not trying to discredit Dan or X-laser. I am sure Dan and his company are very respectable. However, I am massively skeptical that one small company can speed up the federal gov. I work with many different government agencies all the time. I have never seen the government move fast (except when my taxes are late).

    If X-laser has made the paperwork easier that is great. Please understand my concern. If I bought $20K worth of Xlaser for a club install and still have to wait over a year to turn it on... how does this help me?

    Honestly, Good Luck to X-laser and there endeavors. I never want to wish Ill will on good American companies selling American made products.

  4. #14
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    I also can vouch for Dan. What he has done is 100% true. Hes a good guy, good company and this *IS* a good move forward for the industry. *IF* it can be adopted in some ways with other companies and can be used as an example as to how to implement it properly.

    I just stand firmly that whether its paperwork, internet submission, text message submissions, mail submissions, i do what i gotta do. If i dont hear anything back in the 30-60 days or so...im moving forward whether they (CDRH) likes it or not.

    After seeing what wicked has done to get their flame thrower airplane taker downers eye ball poppin lasers into this country LEGALLY, i have ZERO respect for the process and "Safety regulations" implemented.

    I am in this profession, therefore i must follow the rules. Fine, perfect. I do. but im not going to invest money and time and lawyer fees and invent software to accomplish a task that should be done properly in the first place. (Variance process). I really dont care what their excuses are for not being able to accomplish these tasks. Thats fine. you cant hold up your end of the bargain, but i am still required to hold up my end of the bargain!?!?

    like i have been told a million times by other companies and CDRH reps...

    "Marc, run your business. Do what you need to do. Do safe shows, build safe equipment and be compliant and you'll never see or hear from us in a hundred years!!"

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  5. #15
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    I give Dan a thumbs up for taking some initiative and getting things done.

  6. #16
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    If this streamlined system becomes the "norm" for all laser show folks looking to be legal it would be the greatest thing since sliced bread to me. I have no intention of ever buying a laser manufactured by anyone other than myself, and I hope that one day responsible DIYers who can provide proof that their systems are built to standard and that they have a good amount of respect for safety won't have to go through such a mountain of BS that it makes a root canal seem like hot, steamy sex in comparison. If you can't even get straight answers out of the people who really should know, then you know that whole thing's a crock.
    Last edited by ElektroFreak; 09-21-2010 at 14:51. Reason: typo

  7. #17
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    This is not a new concept to the Government. Its done with other agencies. For example, FCC allows companies to submit their own testing of RF emitters such as cell phones and two way radios and networking cards. The rule of thumb: if it runs above 100 kilohertz or a certain emissions level it needs a FCC type approval on file. Just imagine if the FCC had to approve every new cell phone core that came out. Under the old system, a prototype had to be sent to a FCC lab.It would be tested, and a ID number assigned. On the 50s, 60s, and 70s and 80s, that was how it worked. Imagine how slow that would be just for today's new Motorola models alone. For about a decade now, all you do is submit the paperwork and lab results for review, approval is much faster.

    Read laser notices 50 and 55, you'll get some clues about why this was accepted.

    Its not novel, except for its depth. I know Omnisystem and Mobolaser had similar systems in the past.

    This is good for us all, as it allows clubs to have a safe,legal, system instead of illegal imports.

    Yes it does have its downside, but if done right it possibly lightens the load and frees up a few review persons for the rest of the applications backlog.

    One other neat thing, if something goes wrong, there is a corporate officer to hold accountable and a recall or modification is possible. We all know after the recent pointer fiasco, that it is nice, from a safety and legal perspective, to be able to hold some one accountable.



    Steve
    Last edited by mixedgas; 09-21-2010 at 22:03.
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  8. #18
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    I suggest they change it from CDRH to CDRHW

    Center for Delaying Really Hard Work

  9. #19
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    Thanks guys - I appreciate the support and the bona-fides.

    I think that this system has a lot of broad potential especially as the foundation of something larger. Stay-tuned...

  10. #20
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    Quote Originally Posted by mixedgas View Post
    This is not a new concept to the Government. Its done with other agencies. For example, FCC allows companies to submit their own testing of RF emitters such as cell phones and two way radios and networking cards. The rule of thumb: if it runs above 100 kilohertz or a certain emissions level it needs a FCC type approval on file. Just imagine if the FCC had to approve every new cell phone core that came out. Under the old system, a prototype had to be sent to a FCC lab.It would be tested, and a ID number assigned. On the 50s, 60s, and 70s and 80s, that was how it worked. Imagine how slow that would be just for today's new Motorola models alone. For about a decade now, all you do is submit the paperwork and lab results for review, approval is much faster.
    ya but sending something to a lab to be type accepted under 47 CFR Part 15 or Part 95 is really expensive... if thats the future we can look forward too we are doomed lol

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