The basic answer to your question Brad is yes, it is.
Variance holders are prohibited from selling, loaning, leasing, or otherwise transferring (power functional) high powered laser products to persons without variances.
The basic answer to your question Brad is yes, it is.
Variance holders are prohibited from selling, loaning, leasing, or otherwise transferring (power functional) high powered laser products to persons without variances.
Lets clarify that a bit. I can sell you a 500 Watt Co2 no questions asked, provided I'm sure your not going to export it because of ITAR, provided its an approved laser product. Only laser show products, certain Demonstration Laser products, Imports, Medical, and a few other types of devices require paperwork on the customer end. In medical, its pretty much "prove your an MD", and you get the laser.
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Lab or Industrial lasers not classed as a item of interest under ITAR flow freely...
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Steve
Qui habet Christos, habet Vitam!
I should have rented the space under my name for advertising.
When I still could have...
It reminds me of the whole AR-15 thing and which parts are actually the "regulated" portions of the build, the 80% lower, etc. In my understanding, Adam could have removed the laser source(s) from the housing, declared that he's selling you a laser source for "lab use", sold you the housing separately, and leave it up to you to re-assemble it. That's technically legal as far as Adam is concerned as you don't need to hold a variance to purchase a laser for "lab" use.
Steve, what are the rules surrounding purchasing a "lab" unit? How far off base am I?
This is the dirty little secret hiding in the closet of every hobbyist who eventually went on to get their variance. You can't legally sell a laser projector to someone unless it's certified under a manufacturer's variance *and* the buyer has their laser light show variance. But as you said, there is a buy and sell area here on PL where things get sold on a daily basis.
Nearly all of those projectors sold are being used by hobbyists/enthusiast's in their homes. But that doesn't make it legal. It just means that you are flying below the radar. Will the CDRH go after you? Almost certainly not. But if you want to be technical, it is against the law. (See my reply to ryanlightsitup above.)
Absolutely. You are violating the terms of your manufacturer's variance if you do that. Does that mean I think you should stop? No. Use your judgement.if I trade someone a home constructed laser projector in exchange for cutting my lawn for the summer - couldn't that be deemed as a form of commerce?
I definitely told you that they were *not* certified projectors.In fact, at that time, I didn't have my manufacturer's variance yet, nor had I filed my laser product report, so there would have been no way for me to certify those projectors.
Dan, this also applies to the general public, doesn't it? I didn't think you had to have a variance to fall under 21 CFR 1040... So even if someone does not have their variance, they still can't sell class 3B or Class 4 projectors that aren't certified, right? (Playing my own devil's advocate here...)
Funny enough, that's pretty close to what happened. Hank re-built one of the projectors into a larger case at SELEM, and ended up replacing some of the lasers in the other unit as well. Although that was after I sold them to him...
I'm sure we could have gone through some artificial motions to make it "legal" on paper at least, but in the end it was two friends working out a deal to benefit each other. I'm sure the CDRH has bigger things to worry about. The difference (and I'm splitting hairs here) is that I knew Hank was only going to use them in his living room *and* I knew Hank wasn't going to do anything careless with them.
But if someone approaches me and asks me to build them a projector and then certify it for them so they can use it in a commercial show, my answer would be no. That's a huge liability risk I'm taking on, and there's no way I can compete with the prices of other commercial units on the market anyway, so there's no incentive for me to do that. That's why I said I don't sell my own gear.
Adam
suppose you're thinkin' about a plate o' shrimp. Suddenly someone'll say, like, plate, or shrimp, or plate o' shrimp out of the blue, no explanation. No point in lookin' for one, either. It's all part of a cosmic unconciousness.