Variance Help

[eighty8]

Just another word of warning Eighty8, in case you should decide to go with X Laser and to avoid you being caught out a 2nd time, there are now 2 totally unrelated X-Laser companies - 1 in China and 1 in the US, that make totally different projectors. Don't make the mistake of thinking you're buying from the US company by buying from China or of buying 2nd hand without knowing it's X Laser USA. It's my understanding that only X Laser USA is varianced.

Yes, I am well aware of the knock off companies and now which ones can be used in the U.S. Thanks for looking out.

[buffo]

Hello Eighty8; Welcome to PhotonLexicon!

Sorry to hear of your troubles. Sounds like whomever you contracted with is a real shyster. For the record, the lawyer might have been able to help you get your laser light show variance (truthfully, this is fairly easy and several folks here can help you get that as well), but a laser light show variance is useless if the guy who built your projectors didn't already certify them as compliant under his own manufacturer's variance...

Let me back up a bit and explain: There are 2 key elements that are required in order to perform a LEGAL laser show here in the USA. The first part is the laser light show variance, and the second part is using "certified" laser projectors.

A laser light show variance is obtained by filing FDA form 3147 and checking the relevant boxes. You also need to supply some supporting documents (commonly referred to as a "show report", here is a guidance document) that explain *HOW* you will set the laser projectors up when you do a show to ensure that you don't exceed the maximum permissible exposure level for the audience. But overall, obtaining a variance is a fairly straightforward process, provided you don't try to get approval for audience scanning.

Now, the second part (certified projectors) is a *lot* more complicated. When someone builds a laser product, before they enter the product into commerce (which means before they use it for a show or sell it to someone else), they are required to first apply for a laser product manufacturer's variance, and then they must file a laser product report for the product they just assembled. The manufacturer's variance is applied for using the same FDA form 3147, and in fact you can apply for both a laser light show variance and a laser product manufacturer's variance at the same time. But the laser product report is another story altogether.

A product report is a massive document that answers all sorts of detailed questions about how a particular product is assembled. It includes data sheets for *all* components (yes, literally down to indicator LEDs, key switches, buttons, knobs and other switches, plus all of the lasers of course), schematics for all safety-critical portions of the projector, a block diagram of the internals, a copy of the user's manual, and copies of all labeling on the projector, to name just a few sections of the report. You also have to have detailed information on the quality control and testing procedures used to verify that each unit complies with all the requirements. There is a template that you can follow, but the actual report will be much larger. As an example, the last product report I filed was over 100 pages, and I have seen some product reports that exceeded 300 pages!

This document (the laser product report) is the big stumbling block for most people who want to do everything themselves. Getting a laser light show variance approved is trivial in comparison to the effort that goes into filing a laser product report. This is why so many people choose to purchase off-the-shelf units rather than building their own. However, it *is* possible to get a manufacturer's variance approved and file your own laser product reports. There are several members here on PhotonLexicon who have done this, and should you choose to go down this path, we will definitely help you along the way.

But if you want to be doing commercial shows in a month, then the "do it yourself" path is not the way to go. It took me about 8 months to write my first product report, and that was with the assistance of Casey Stack at Laser Compliance Inc. (Casey is an industry expert with decades of experience in dealing with the CDRH, but his assistance does not come cheap!) So if your goal is to be doing shows soon, you are better off purchasing an already-certified projector. As an example, X-Laser USA was mentioned above... They sell certified laser projectors, and they also offer an "EZ-Variance Kit" that will get you your laser light show variance in about 30 days. I highly recommend them, and in fact the company president (Adam Raugh) is actually a member of the forums here on PhotonLexicon. (User ID: Araugh)

Finally, I would strongly encourage you to attend a Laser Enthusiast's Meeting in the near future. We have one scheduled for March 1st-10th (The Caribb-LEM), but that one is being held on the island of Utila off the cost of Honduras in Central America. Thus, unless you can schedule some vacation really quickly (and you already have your passport), you might not be able to swing that trip. (If you can, it's going to be amazing though: SCUBA diving and beach activities by day in a tropical paradise, with laser fun in the afternoons and evening, all for a very affordable price.) But in the late summer (August 8th through the 14th, to be exact), we will be hosting the 11th annual South Eastern Laser Enthusiast's Meeting (SELEM) in Newton, North Carolina. This is the big daddy of them all, and it's an event you don't want to miss. Search around in the meet-and-greet sub-forum to learn more about SELEM and read about what went on at past events.

And again, welcome to PhotonLexicon. It's a shame you didn't find us sooner, but now that you're here you'll find that there is abundant help available from all sorts of very cool people. If you have questions, just ask! (It's what we're here for.)

Adam

PS: Some helpful links if you'd like to research the US regulations some more

http://www.fda.gov/Radiation-Emittin.../ucm202505.htm
http://www.fda.gov/Radiation-Emittin.../ucm118907.htm
http://www.accessdata.fda.gov/script...cfm?fr=1040.10
http://www.accessdata.fda.gov/script...cfm?fr=1040.11
http://www.accessdata.fda.gov/script....cfm?fr=1010.4

[eighty8]

Adam, wow that's a lot of useful information. Thank you for taking the time to write it. I knew the basics, but this really goes into detail. Thanks!

[eighty8]

So just thinking, if I have a variance to operate a system that only allows myself to operate it can I have a backup person? Say in the event that I got sick and couldn't run a show that I was paid for, could I have a backup operator also get a variance that is separate from mine to operate the system? Can any member that already has a variance operate my systems or is it tied to a specific manufacturer/projector?

[Bradfo69]

Yes, you can designate someone like a backup person/employee to run your systems. My variance for example is in the name of BB Laser Productions so, basically an employee of BB Laser Productions can run the lasers... I'm just the responsible party. I think most variance holders tend to be in company names anyway.
.
Yes, anyone with a variance can run your legal varianced projectors. Say you borrow or rent one of my projectors since your short for a show. Or you rent me one of yours. You're covered.

[buffo]

My variance for example is in the name of BB Laser Productions so, basically an employee of BB Laser Productions can run the lasers...

Just a small nit-pick here, to clarify for others (I know you know this already Brad)... Anyway, your variance allows you to designate any employee of BB laser productions (who has been properly instructed) to operate your lasers, but it also allows you to sub-contract the operation of your lasers to others. So the operator technically doesn't have to be an employee of yours.

However, you are still on the hook if anything goes wrong, because the show is being done under your variance.

Adam