X-Laser

[DanG]

Adam,

I wish I could but sure can't. This is one of those situations where you would never get a letter from the chief of police saying that you are allowed to go 56mph in a 55 zone but in all reality, no one will ever make an issue out of it. Moreover, the FDA is compelled by the civil suit to support that interpretation of the rules not to re-write the rules. My understanding of the civil suit was that it was settled out of court b/c the goverment did not have a case.

I am the type of guy who likes to see it in black and white but that is just not going to happen here.

[buffo]

If this came out of a civil lawsuit, the information should be publicly available. Even settlements are usually not private unless money is involved. At any rate, there should be some record of the suit being filed. Do you have any information about this lawsuit? When it was filed, who brought the suit, when it was settled?

As for the re-interpretation of the rules, that's what laser notices are for. For example, Laser Notice 50 allows manufacturers to ignore large sections of 21 CFR 1040.10 and .11 if they instead choose to certify their laser product under the IEC standards. (Specifically, IEC 60825-1 and IEC 60601-2-22.)

Note that this is a significant re-interpretation of CDRH regs that was brought about by a challenge under the "least burdensome approach" philosophy. It is every bit as much of a change as your suggestion that people can operate without a variance so long as they've submitted the paperwork. The difference is that Laser Notice 50 did not result from a lawsuit challenge.

So if the CDRH issued laser notice 50 for a change to the laser product report guidelines, does it not seem logical that the CDRH would also have issued a laser notice concerning variance applications? (Especially if the change came as a result of a lawsuit?) Yet you stated that there are no official documents to support this change. That doesn't fit the pattern of previous CDRH behavior on matters such as these.

I'm sorry, but without concrete proof, I think you are walking on *very* thin ice here. Where did you get your information about this change? (Whom have you spoken with at the CDRH?)

Adam

[DanG]

Adam,

All good points and I agree but I simply cannot tell you why it was not the subject of a laser notice though that would be a good question the next time I speak with Dale. In answer to your other question, the policy was set with Frank M. before he retired and was approved as part of our manufacturer's variance under the terms set forth above along with a few other proprietary provisions that relate to our operations. That is our confirmation which has held up under several inspections (most recently last week) and several dozen end user inspections who were all operating under this policy.

Given all of that I have never felt the need to go hunting for the civil case and since it has been approved, at least within the framework of our methodology, I consider that as concrete as it comes (short of a laser notice of course). Without such confirmation, it would have been absolutely insane to base a business upon a faulty or otherwise thin operational premise.

Thanks!

[gottaluvlasers]

I gotta be honest here-

X-Laser...

I am very impressed as to your attention to this matter and the responses you have given here. You seem to be a very professional company with its customers, legalities and safety in mind. I think you have earned some respect by your professionalism with the situations here.

As you can tell, We as a community here, are very "protective" (if thats the right word to use ) about our profession and hobby. Laserworld has gone well above and beyond to prove to the laser community that they are quite simply out to make a few dollars and *do not* value this industry and treat it with respect. I know that probably sounds corny, but in my eyes, it isnt. Most laserists here (pros and hobbyists alike) take quality, service, safety and ethics VERY SERIOUSLY!! Like i have said a zillion times (and you have said also) A company will always make mistakes. I make them, you make them, the best companies in the world makes them.

however-

How those comapnies handle their mistakes is what proves what type of character and what type of dignity that company posesses. And Laserworld has proven time and time again that they do not posess ANY of those qualities. When does a mistake turn into a pattern? When does an excuse turn into a lie? when does the bull crap get piled too high where it starts bursting at the seams?

Its like the old saying, "fool me once, shame on shame on you. Fool me twice, shame on me." (i think thats how it goes. lol )

I honestly hope, and it seems to me that this is the case, you do the right thing! Becasue the bottom line here is the lies and deceit from Laserworld spread FAR past this forum and this thread.

If they just "did the right thing" we wouldnt have 10,000 pages of Laserworld bashing here. the bashing has nothing to do with not knowing how to meter a beam of light. Has nothing to do with conspiracy theories, has nothing to do with users not knowing how to operate their lasers. It has to do with blatantly selling sub-par, outright not-as-advertised and/or promised products!

As far as the variance issue-

I have to agree with you on this one X-Laser.

Adam- this has been confirmed (not by me personally) that this is the "un spoken" accepted standard. I have heard this quite a few times form multiple sources from multiple trustworthy and "in the know" type of people.

As far as any official notice of it?!? dont know. But we cant base anything off of a lack of a notice. We need to remember, this is a regulated industry in which the regulators have no idea how to regulate and enforce.

Yes, of course, blatant disregard for the laws and regulations will get ya in deep sh*t. But for people who are doing the right thing and better yet, *ATTEMPTING* to do the right thing, the "look the other way" approach i think is pretty much the norm.

DISCALIMER-

please realize, i am in NO WAY tellying anyone to go out and begin to do shows and or builds without following the procedures. But there are protections for us as laser companies and manufacturers also trying to run a business.

I have 2 customers that are still waiting for variance approval letters. 1 was completed and sent in twice! and have been completed and acknowledged in July! This is only for a 500mW RGB projector using a CERTIFIED enclosure. So, its getting to the point that the FDA/CDRH are hindering people from performing their jobs and running their business!

there is absolutely no reason for the FDA to take almost 6 months to approve a variance for an LT1000 500mW RGB projector. there is just no excuse for that!

you would be extrmemly surprised as to what companies operate with this understanding of the "gray area" on their side. It is just one of those accepted norms.

-Marc

[DanG]

Marc,

Thanks for that and I agree very much. We have had dissatisfied users in the past, but they are few and far between and we have always gone out of our way to correct the problem as best we can. Most of those folks fall into the "pay the least, want the most" category but we do try to do whatever we can regardless. Sometimes we just have to say sorry - a 10K scanner is just not going to do THAT.

I suppose I am more curious than anything about how this reputation came to be because having met with and worked with the laserworld folks for a bit now they seem to be honest, decent people. I cannot possibly discount the experiences here, I just have great difficulty reconciling the two sets of experiences and perhaps it is time that will tell.

One thing that we are looking forward to is a retrofit program whereby we can bring existing EU models in the US currently into FDA compliance and certify them under our QA process. Perhaps that may help to correct some of the issues out there in the world. While it would not be free as one may expect from warranty service (since we are not the manufacturer), it would be one avenue that folks could explore with us if they were so inclined.

In any case, you all collectively should be protective of your profession/hobby as I am of both of mine. Laser folks are constantly under siege from regulators, inspectors, clients, manufacturers and pretty much the entire country of China. I would never fault you for that because as a professional magician before I got into being a laserist I understand full well what it is to be in a profession constantly under scrutiny and siege (if that is the right word).

As always, I am happy to answer any questions or discuss any of the finer points anytime. At the very least, we do our best to be accessible to our users specifically and the larger laser community in general.

[allthatwhichis]

I suppose I am more curious than anything about how this reputation came to be because having met with and worked with the laserworld folks for a bit now they seem to be honest, decent people. I cannot possibly discount the experiences here, I just have great difficulty reconciling the two sets of experiences and perhaps it is time that will tell.

Hey Dan, thank you for joining; I meant to try and meet you at LDI but I left a bit early. I spoke with Adam and I think John who showed me around the booth very well.

This... http://www.photonlexicon.com/forums/...ead.php?t=7009 is how the LaserWorld reputation came to be... They didn't debate too well after the projectors they sold got reviewed here.

[Andrew_D]

Dan,
These youtube video reviews of Laserworld pretty much sum it all up, and the video is in line with the many reviews on this board.
We have all seen these before but you may not have had the chance.
The results speak for themselves...and it's the exact same problem happening over and over and over again...

http://www.youtube.com/watch?v=JgYL7KmnFk8

My question for you is, if you can submit product reports for Laserworld projectors to obtain variances, why can't you do them for your own and leave them to themselves?
I mean, what does Laserworld do so well that X-Laser can not do? Sub-assemblies?
You recently came out with the Mobile Beat and the RGBV projectors that both looked AWESOME. The XA100 that I reviewed was great as well.
I guess I dont understand why you need Laserworld to be a part of your company.
You were doing fine on your own!

[allthatwhichis]

Andrew, that video is part of the problem; the other part of the LaserWorld problem started about here... http://www.photonlexicon.com/forums/...7&postcount=19 With their first reply to Marc's review, from Peter. And it went down hill from there... well, it is still an active thread so I correct myself by saying it continues to go down hill. Maybe this partnership with X-Laser will help LaserWorld, but I think our fear is that it may also hurt X-Laser more than it helsp them; and are we sure they deserve help.

[mixedgas]

Andrew, that video is part of the problem; the other part of the LaserWorld problem started about here... http://www.photonlexicon.com/forums/...7&postcount=19 With their first reply to Marc's review, from Peter. And it went down hill from there... well, it is still an active thread so I correct myself by saying it continues to go down hill. Maybe this partnership with X-Laser will help LaserWorld, but I think our fear is that it may also hurt X-Laser more than it helsp them; and are we sure they deserve help.

Guys, before you project Laserworlds Image onto X-Laser, remember two things.

One:
He did post here in a friendly and professional and informative way.

Two:
Since he is a US rep, he has to stand by the product and repair/replace it. Since he has a healthy dose of respect for U.S. safety rules and liability concerns, I'm willing to bet he takes good care of his customers. Lets find out before we turn this into a LW slugfest thread.

I'd like to applaud him for explaining the special status with CDRH.

It made me realize that my Merlin series projector design is actually worth something, and reinforces my sometimes business partner's theory that having a approved manufacturer's report is worth something. I have always argued that our approved, small, projector design was a joke if we tried to sell it against a unapproved Chinese import, because we would have to wait for a customer to be cleared by DC. We had always thought we could NOT sell Merlins until the paperwork cleared. I'm now thinking I was wrong on both counts. Not that I'm going to try to go head to head with anyone, but you can bet we will not be turning down some small installs in the future, as we have in some cases in the past.

Steve

[allthatwhichis]

I posted that with nothing but respect; my point was to show Dan where LaserWorld's reputation was earned here on the board. I sincerely hope LaserWorld's reputation does not harm X-Laser's as much as I am sure X-Laser's will help LaserWorld's. Dan's first few posts here have been 1000% more positive than any post from anyone directly related to LaserWorld and I look forward to the results from this relationship. I really like LaserWorld's best case design. Before I got the Kvant I looked at sniping several eBay auctions just so I could gut the case and install the components I had.

Again, nothing but respect from me.