What is a variance and Hdo I get one?

[skiezdalimit]

What is a variance and how do I get one? Is there a cost? How long is the process and whered do I apply for it?

[mixedgas]

Variances are free. The paperwork involved is not bad if you take it one step at a time. You have two packets of paperwork to complete. One is for the hardware, the other is for your use of the hardware. You may submit them at the same time. You may need to add a simple beam shutter to your projector and a few other parts and warning stickers. Be sure to write your varience so that you may own upgrades and other projectors in the future without a amendment.

There are plenty of people on this board who have done this recently. As my personal variance is for very complex hardware, done long ago, I will defer to them for assistance in your case. The rules have changed a bit, and your not using a 3 laser 30 watt system with auxillary projectors and KTP certification, like mine.

So you'll need a manufacturer's report, and a variance application to use the hardware approved in the report

Its actually just time consuming. FDA has been doing turnarounds in a month or two lately. Which is amazingly fast, as mine took six months some years ago.

BTW, drop all of this into one thread, Called "Helping a Newbie, I'm new at this" or some thing like that. Otherwise no one will reply. You have like 9 threads open. You'll get more help if its all in one thread.

We dont really have moderation, however the Janitor is known to excise thread floods. Once you get one good thread up, I'll ask him to nuke the other ones.

Much of what you are asking can be had by searching the site. Enthusiasm is good, however!

Steve

[buffo]

Seconded on everything Steve said. Use the search function here on the forums and start reading. Suggest you start with the terms "CDRH" "Variance" and "Laser Product Report". Lots and lots to learn.

Do you already have a projector? If so, did you buy it or build it? Most importantly, do you know if it has been certified as compliant with 21 CFR 1040?

Self-certifying a projector can be done, but it is a long process that will require a good bit of learning on your part. If you plan to build several of your own projectors though, then this is probably the route you'll want to take.

On the other hand, if you just want to get up and running with a legal, certified projector right away, then you would be better off purchasing a pre-certified projector from X-laser and applying for your laser light show variance using their EZ-Variance kit. You could be legal in as little as a month. (2 months tops)

But keep this in mind: It is against federal law to use a laser projector in any commercial endeavor without first obtaining a laser light show variance *and* ensuring that the projector itself has been certified under a valid laser product manufacturer's variance as well.

So if you don't want to do all the paperwork yourself, then talk to the folks at X-laser.

Adam

[dsli_jon]

Hello skiez

Welcome to PL.. 'buckle-up'.. ..then again, you're from TX, so nothing outta 'scare' you, right? I can third everything the fellas just said to ya, but as couple small additional thoughts:

So you'll need a manufacturer's report, and...

(..not commenting @ you, Steve, just quoting to springboard / clarify.. ) Only if you intend to build - or modify something you buy - your own projectors / use in public for shows... Otherwise, you would get the 'Accession Number' (..think, like a 'library-book number' - something the Feds use to 'reference' an already-submitted report about a projector / family-of..) for an already-Certified PJ, here in the US.. Once you have some experience / training, many Co's will also give you their Projector Acc's #s, so you can 'add' those PJs to your own-Var, for doing 'cross-rentals', should you ever need to do-such.. A common practice in the biz, but.. untill you have some experience / training, unless you're already 'in-tight' w/ some Co, you prolly won't get those just 'handed-out'...

Suggest you start with the terms "CDRH" "Variance" and "Laser Product Report".

Gents, gents - Are we forgetting our supermegaawesome Wiki? http://www.photonlexicon.com/wiki/in...itle=Main_Page

@ skiez - First, start here, with this simple-yet-thourough 'Overview PDF' - read the entire thing: http://www.fda.gov/downloads/Medical.../UCM119257.pdf -

..then, you can get a better 'overview', here: http://www.photonlexicon.com/wiki/index.php?title=CDRH.. and, since you do-live in a State where they *also* have State-level Regs / registration-requirements, this page: http://www.photonlexicon.com/wiki/in...te_Regulations - with the associated-link, will get you honed in the right-direction..

..If the PL-search engine did not suck so-bad, I could find you all the links I posted-up for someone awhile-back, specific-to the TX-Regs links / current contacts, etc.. Once you get to that point, (..have-selected a PJ / filed your FDA-Variance / get your Acc. #, etc..) shoot me a PM, and I can give ya what I got on TX-registrations, and let you run from there... But, in any-case..

But keep this in mind: It is against federal law to use a laser projector in any commercial endeavor without first obtaining a laser light show variance *and* ensuring that the projector itself has been certified under a valid laser product manufacturer's variance..

Heartily-thirdeded.. Shoot and fly straight, from the get-go - you'll get much further-ahead, in the long-run..
cheers..
j