I will pay you $100

[DanG]

Seriously.

I have a little pet peeve and I am willing to put my money where my mouth is to either hopefully settle any debate or be proven wrong. If I am wrong, I will happily pay the first person to prove it to my satisfaction - and I will endeavor to be fair - $100 for their trouble by paypal or business check.

Throughout this board and occasionally in conversations people refer regularly to projectors being "varianced." This is my issue because I have always contended that laser projectors cannot be "varianced" and I get into disagreements about with very well meaning folks. So I would like to try and settle this for my own sanity if nothing else.

My understanding in a nutshell is:

A "variance" attaches to a person or organization.

A "certification" or product report attaches to the hardware used by the person or organization.

A variance identifies the owner or manufacturer of the laser equipment, describes in general terms how the equipment will be used, describes the basic characteristics of the equipment (power levels, wavelegnths, etc.) and permits the owner to use the projector(s) in very much the same way as a driver's license allows one to drive a car.

The product report describes in detail the attributes of the projector, how it is manufactured, how quality assurance as it relates to safety is to be performed, etc. and is approved by the CDRH (the filing is approved, not the "projector" itself) allowing the projector to be sold or otherwise conveyed to an individual with a variance or otherwise introduced into commerce. This is analogous to the many reports generated from the safety tests that cars undergo before they can be sold to consumers.

A car cannot be granted a driver's license and a driver cannot be crash tested to prove that he/she meets the Federal regulations for a motor vehicle.

Extending the metaphor, a projector cannot be varianced and a user/show is not subject to a product report.

So the challenge is this: I would like someone to clearly prove to me using laser notices, federal regs or some other authoritative source with force of law that a projector can be granted a variance.

I honestly do not think that is possible but I am open to a debate and happy to be proven wrong so at least I can get on the same page with others if I am mistaken.

My feeling is that more often than not this is a colloquialism among laserists which while not technically accurate is a shorthand for those in the know. In that case, I would suggest for discussion that we as a community - and I am acutely aware that I am reasonably new here so I hope i am not way out of turn on this one - endeavor to use language that is a little more specific just so that our new members can develop a clear idea of what they need to do to produce safe, legal shows without the terminology getting more confusing that it already is.

Anyway -there it is. Release the hounds.

[flecom]

man if even you guys can't answer that question what hope do the rest of us have? lol

maybe we will get lucky and the budget cuts will eliminate laser show projectors from the CDRH's scope of work and we can go to something not quite so insane...

you know, or just do shows illegally like pretty much everyone else

[ArcDevilz]

http://www.fda.gov/ohrms/dockets/dai...00/var0001.pdf

It is my understanding that a laser device can be given a variance . It clearly states so on the form. A variance can be assigned to a laser light show or device. The form for Mobolazer appears to be a filing to receive permission for their product lineup. The device appears to have been granted approval from what I can tell because they where able to sell the higher powered systems.
Can an approved device perform a show that cannot pass a variance test? Sure.

the Director of CDRH may grant a variance for a product. That is one of the lines on page 19 of their document on variances.

A variance (1010.4) is permission to vary from one or more requirements of the standard. Upon application by a manufacturer, the Director of CDRH may grant a variance for a product if it is determined that the variance is so limited in applicability that an amendment to the standard is not justified, or is of such need that there is not sufficient time for amending the standard, and that granting the variance is in agreement with the Federal Food, Drug, and Cosmetic Act.

[Mattatya]

It does get confusing in the wording for me.

On the Omnisistem Q-Beam made by Pulse laser systems it states in their operation manual

Q-Beam Manufacturers CDRH Declaration
The Q-Beam projection system is in conformance with the performance standards for laser
products under 21 CFR part 1040, except with respect to those characteristics authorized
by variance number 96V-0168, effective 6/20/1996.

To me that indicates the that laser has a variance number 96V-0168. And it's under 5mw even.

[JohnYayas]

I don't know what the regs say in this case but logically it completely makes sense to me if it it so. The variance is basically to allow use of lasers that exceed the normally allowed levels due to safety mechanisms that are in place. The variance applies to the lasers but within the context of the projector that contains them and the safety devices. If the projector did not have a variance for the lasers within it, then that would mean that the projector would have to be dismantled and destroyed if ownership transferred to a different person. Clearly, that is not the case.

This doesn't mean that the projector is safe in the hands of an idiot, though. So, there needs to be additional controls over who is allowed to use the projector. But, those controls can be seperate from the variance that applies to the lasers in the projector. In fact, one of those controls would be that the person who is doing the laser shows must only use projectors that are underpowered or have a variance for containing overpowered lasers.

Again, I don't know if what I am saying matches reality. But, logically, that is the way I think it should be.

[ArcDevilz]

This doesn't mean that the projector is safe in the hands of an idiot, though. So, there needs to be additional controls over who is allowed to use the projector. But, those controls can be seperate from the variance that applies to the lasers in the projector. In fact, one of those controls would be that the person who is doing the laser shows must only use projectors that are underpowered or have a variance for containing overpowered lasers.

Again, I don't know if what I am saying matches reality. But, logically, that is the way I think it should be.

You are correct. The device can receive a certification number and conform to the guidelines set forth. This does not mean that you can run around and do shows at your own accord. You still have to get a variance for the show you will be doing. If you look up Mobolazer projectors they where denied a variance at multiple clubs in Hawaii because there systems where not in compliance. It probably means that the laser beam where not aimed at a height that was satisfactory to the compliance measures.


This text was taken from the FDA's site.

Laser projection systems and light shows manufactured, assembled,
produced, or distributed under this variance shall not be transferred
to any other party until the recipient has demonstrated that they have
a variance, as required, in effect that permits them to produce
certified laser light shows incorporating these laser projection
systems . A notation of the recipient's variance number and its
effective date, as applicable, shall be entered and retained in the
records of compliance test results required by 21 CFR 1002 .30 .


So you see it is simple. Your device has to get a variance to be sold. But the person you're transferring the device to has to get a variance for the device in order to use it for public use. It is unfortunate that you cannot transfer a variance from an approved product and that the new owner has to variance the same item for whatever use they will use it.

It's a shame that you have to do all this work in order to sell laser products made in the US. If the CDRH or FDA had any real concerns about laser safety they would contact Ebay and shutdown all black market Chinese systems.
If the Chinese manufacturers followed the these rules that govern laser safety they could not keep up with the paperwork and not be able to sell their products legally.

[gottaluvlasers]

Dan-

#1- You are asking a question that to this day the CDRH, Casey, God him/her/itself cant cant answer definitively. This is what i brought up to Casey late that night at SELEM.

#2- *MY* understanding is YES, a device does have to obain a variance in addition to the person. The variance is granted for that exact purpose. It allows the device to "vary" from the standards of 21 CFR.

#3- I cant elaborate more cuz im on my way to do a show with my varianced projector! LOL (seriously)

-Marc

[beamann]

Dan-

#1- You are asking a question that to this day the CDRH, Casey, God him/her/itself cant cant answer definitively. This is what i brought up to Casey late that night at SELEM.

#2- *MY* understanding is YES, a device does have to obain a variance in addition to the person. The variance is granted for that exact purpose. It allows the device to "vary" from the standards of 21 CFR.

#3- I cant elaborate more cuz im on my way to do a show with my varianced projector! LOL (seriously)

-Marc

@ Marc,I knew it was just a matter of time for you to post on this, now I am waiting for buffo to post here.

As far as my reserch gose from what I learned at Casey Stack laser safety seminar and a frustrating web serch FDACDHR and related, All laser projectors made in the U.S. have a MFG's variance and when the projector is sold to some one here in the U.S. the MFG's variance gose with it and is documented as so, and the variance is tranferable as long as the projector is not modifide in any way from the MFG's oridginal variance issuded.

Casey Stack (laser compliance)"www.lasercompliance.com he is the man and shure he would like the houndred dollors if not anything, the chalange to educate us.

[DanG]

OK -

So I have done a little digging to address the replies here and I will do a little more before I respond in detail but in the interim, let me just ask a simple question and make one clarification. The question is up first:

If a manufacturer has to submit a product report before they can have approval to introduce the product into commerce and,

If a manufacturer has to obtain a manufacturer's variance before the product can be made and,

If a user has to obtain a variance to use the product once it has already been product reported,

What would the purpose or effect of having a device specific variance be?

Allowing you to "vary" from 21 CFR 1040 is not a sufficient answer IMHO because permission to do that would either have already been granted, or would have to be granted through one or more of the mechanisms above.

All the bases have been covered because the device's composition, intended use, safety and QA is addressed in the product report (often referred to as FDA3636), permission is granted to the manufacturer to make it in the mfg variance (FDA3147) and the customer variance allows them to use the product (also FDA3147 but different).

I also want to make sure that we draw a distinction here between being given permission to use or make a specific device as is established by the clause that Arc copied: "Upon application by a manufacturer, the Director of CDRH may grant a variance for a product"- and permission being given to the device itself... to I don't know... exist.

To me there is a difference - in fact a BIG difference - between a device being being built and certified under a MFG variance and a variance being granted to a device irrespective of the process by which it was made which would be the case if someone only had to fill out FDA3147 and not a product report. In fact the sticker that is required to go on top of the thing is required to say something to the effect of "...device complies with' blah blah 'except for deviations pursuant to manufacturer's variance [variance number here].' No where that I know of are you ever asked for a **device's** variance number.

I am going to need some Captain to get much further with this I think.

[Mattatya]

I prefer Morgan