X-Laser

[Laserman532]

LOL... What part of introduced into commerce is confusing

Effective August 20, 1985, all manufacturers or assemblers of Class IIIb or IV laser light shows, displays, and devices manufactured or assembled after that date must have an approved variance before introduction into commerce or continuing their operation.

everybody is looking for a loop hole.

[buffo]

Read # 6
http://www.planetdj.com/images/forms...structions.pdf
Proven.

Proven? Um, not quite. If you want to prove that it's legal, you need to cite chapter and verse from the Code of Federal Regulations, not some BS that the manufacturer claims...

Show us in 21 CFR 1040 where it states that you can operate that laser projector without a variance on a "pending approval" status. Otherwise you're just repeating what the manufacturer is saying, which doesn't "prove" anything.

Adam

[Andrew_D]

Food for thought:

Dan Goldsmith, the president of X-Laser is on Youtube explaining this.
I am not telling you to defy the laws, only writing about what this USA based company is telling it's customers.
X-Laser has obviously done some homework on this otherwise I doubt they would endanger their customers and themselves. The party would be over for them quickly if it was just hoopla.

I am a variance holder, and I did it the real way, and waited 4 months for it, but this does appear to be somewhat of a loophole.

http://www.youtube.com/watch?v=YXJKo...eature=channel

skip to 4:30 for the answer.

[gottaluvlasers]

lets ease up a lil bit here guys....

I know andrew. hes a good guy. not trying to break any laws. i just think he is relaying what *he* was told from this company.

I'll be honest, I have actually heard the same exact thing regarding the "ok to perform while waiting loop hole" from a CDRH source.

now i *am not* i repeat, i am *NOT* saying that it is 100% true or proven, but i have heard this previously from a CDRH rep and from a different laser company.

Something about the FDA/CDRH not having the authority to hinder ones business. If the paperwork has been submitted and your equipment still meets all safety and regulation/variance conditions, you can perform the shows in accordance with what your variance was applied for.

Please understand...i nor andrew i am sure, is telling anyone to break the law. but i *have* heard this before. Whether it is true or not, i have no idea.

-Marc

[Laserman532]

You are probably correct that a rep of cdrh can give the "verbal go ahead" (unofficially) while the paperwork is in review would not surprise me.

The law as stated "entered into commerce" was an all out stop for those who had the where with all to quickly manufacture a faulty product, dump in the marketplace and potentially harm others (as with a poor detector or interlock as used in a medical system) before the NCDRH had an opportunity to catch any products in non compliance.

I would guess that the authorities could slightly turn their head for a single light show guy doing his thing prior to receiving the variance.

I would not stake my business on something the manufacturer might say.

[Andrew_D]

The laser projectors from X-laser (in this case) have already been approved with a product variance and they meet the requirements for class IIIB safety.
The operator's show variance is what the "loophole" is about.

I plan on meeting with X-Laser next week at LDI in Florida and I will ask about more info on this subject or maybe even request that Dan from X-Laser report here to you guys directly.

X-Laser is staking THEIR business (and the business of their 40 or so US dealers) on the fact that there is something to this.

[slicklasers]

I am a varianced manufacturer of lasers also, and I can tell you that once you have submitted the paperwork for a variance for you with a show report on an already varianced product you can perform shows, but you must file with them for every show. I do it all the times for my customers as every laser I sell I also do all the paperwork for their variance.

[mixedgas]

[QUOTE=Laserman532;123636]You are probably correct that a rep of cdrh can give the "verbal go ahead" (unofficially) while the paperwork is in review would not surprise me.

The law as stated "entered into commerce" was an all out stop for those who had the where with all to quickly manufacture a faulty product, dump in the marketplace and potentially harm others (as with a poor detector or interlock as used in a medical system) before the NCDRH had an opportunity to catch any products in non compliance.

Here is my take on this, Omnisystem and these guys may have a letter of agreement with CDRH on this, and can get away with it. And once they have one unit of a given model varianced, I'm sure its a rubber stamp for that design as long as it stays within the bounds of the manufacturers report.

My two one offs would not and did not go into commerce before I had the permit, nor would I encourage a person building a single projector or selling a single projector to another individual to go into commerce without the approved paperwork.

A large corporation is more likely to be allowed to do this, then somebody who makes 1-2 units.

Considering what Slicklasers has done in the past, I'm quite sure he would be trusted to do this properly.

What I would worry about, is what Pat said, and what we have a example of, in Allen Analian, where somebody uses this as a excuse to go in half baked. Oh, I filed, so I'm golden. I think the key words here, as a slicklasers said, one unit has mad eit through the process and we are churning out identical units.

Steve

[DanG]

Ask and ye shall receive...

This is Dan from X-Laser and I wanted to see if I could clear this up a bit. Right now it is taking the FDA around 2 years to approve most non-manufacturing, pre-produced performance variance applications. That is too long for any means of normal commerce so a lawsuit was filed for restraint of trade years ago and the net result was that the FDA allows the use of the laser product while the variance app is moving through the process. This is true with the following caveats:

1) The paperwork must be filed completely via a traceable method (for your protection) so that it could be tracked if lost
2) The user must file show notifications per the conditions of their variance
3) The user must obtain at least a base level of training prior to performance (which is included with all of our IIIB/IV products
4) and the user must adhere to the required safety clearances, etc. during their performance as required by the terms of their variance.

This has been confirmed to us by the CDRH, our compliance consultants, and not for nothing has become common practice in the industry AS LONG AS the manufacturer has an APPROVED product report, show report, and manufacturer's variance as well as properly filed FDA2877's and annual reports.

However, you are not going to find that in any Federal reg and for those of you who work in and around the govt that should come as no great surprise. Over 30 of our users have been inspected in the past year and 100% were found to be compliant.

Hope that helps!

I am happy to answer any other questions you all may have, anytime!

Dan

[buffo]

Dan;

Thank you for taking the time to join the forum to discuss this matter.

Can you link to (or provide a scanned image of) the document you received from the CDRH that specifically details this exemption?

Adam