FDA approval

[dsli_jon]

Jim -

...Looking back...I see that you can never win by under pricing your services or trying to make something or sell a service cheaper than the other guy. All you do is drive your own market down and you will get tired of working for free or losing money. ...Now go and make a Better Case and not a Cheaper Case

I raise my glass to you, Sir! A-MEN!! Really guys, the problem is more the illegal imports, than Co's here, selling a box, fairly-priced for all the effort it does take... And yes, the 'certification process' is rather 'Draconian'...but hey - it's the US Gov - 'draconian' is their middle name! ...I'm gonna go post other at LED's thread about that in a sec...

Kudos and Thanks to you, Edison, for your efforts to sell a Certified, and hopefully, relatively economical case, here! Way to 'show' other 'would-be sellers' of US-import boxes how it should-be done (vs all the cheap illegals...) - I will look forward to seeing your product line....

EF - Kudos to you for giving it a go, and for offering to help post the 'process tutorial' - I'd be happy to help, but I am way too busy to give dedicated blox of time, right now - really, shouldn't even be spending time posting here, right now... (but you know how it is...'moth to the flame'... ...Perhaps down the line I can toss-in some practical help...

Meantime, Thanks, Marc, for posting those linx...

peace...
j

[ElektroFreak]

I agree 110% norty! In the case of 21 CFR 1040 (the actual US laws and requirements for laser systems), the words are relatively plain english and it's not overly difficult to understand so far (I just finished reading several sections). The structure, on the other hand, is nearly impossible to follow without very careful observation of context. It does not specify which parts of the document are directly relevant to laser show systems, so I guess one must view the projector as a whole as being the same as an individual laser source. The same interlocks and safety features are required, and also safety features for scanning systems (scan fails). Other than that, I don't see any real requirement for the shape or structural elements of a case so far in my reading. Every regulation I've seen so far applies to a laser system as a whole, so I really don't see just how an empty case is "certified" at all. Once again, I'm guessing that any case that has been used in a system that has been approved by the FDA would be considered a "certified" case (correct me if I'm wrong).. Perhaps an empty case might have some interlocks built in, but in the case of the LT-1000 there don't seem to be any interlocks that I've seen. Also, the LT-1000 is HUGE. There must be some sort of allowance for smaller cases.

[mixedgas]

Edison,
If you are going to build a case and get it certified make sure you can make a profit on it. As Jon said there is way too much undercutting in the industry right now. In fact I'm thinking of selling everything I have and buying a Lawn Mower, it appears the Lawn Care industry might be a good option in the U.S. right now.[/QUOTE]


One thing, there is more to it then having a accession number for the case. There are recordkeeping requirements, and the fact that Edison may NOT be able to ship you the case until the variance is approved. Some vendors have a arrangement with CDRH that they can ship pre variance, but its generally not for high power products , external lasers, empty boxes.....

Edison, could in theory, have to recall or distribute modifications to the projectors etc... I've installed a compliance retrofit kit on one commercial laser product, it happens..

Steve

[norty303]

I suppose thats one of my fundamental problems with the whole 'case' thing, as the 'case' shouldn't really have any effect on safety systems, other than to have some interlocks (and didn't someone say that the interlocks were confirmed as not required if labelled about non-user serviceable parts inside? Marc?) It is purely a platform for the components, which would comprise any safety elements.
I bet there is no load testing done on a certified case to ensure the rigging system can support 10x projector weight, so again, it can't be from a safety aspect.
I think part of the reason why this is really a non-issue is that nobody is genuinely going to fly a few/many thousand pounds/dollars up in the air in a case not capable of holding it there safely. It's sort of self regulating.
It really does seem like money for old rope.... silk rope, with gold braid

[blowfly]

I suppose thats one of my fundamental problems with the whole 'case' thing, as the 'case' shouldn't really have any effect on safety systems, other than to have some interlocks (and didn't someone say that the interlocks were confirmed as not required if labelled about non-user serviceable parts inside? Marc?) It is purely a platform for the components, which would comprise any safety elements.

My understanding (which is quite likely wrong) is that a case is not certified. A completed projector is certified. Once a projector is certified, you can replace components (usually lasers) and then file a product update report. The upgrade report is just a couple of pages. In this way, a case is considered certified because it just takes an upgrade report to get variance on a projector made with the case.

Mike

[mixedgas]

My understanding (which is quite likely wrong) is that a case is not certified. A completed projector is certified. Once a projector is certified, you can replace components (usually lasers) and then file a product update report. The upgrade report is just a couple of pages. In this way, a case is considered certified because it just takes an upgrade report to get variance on a projector made with the case.

Mike

IF you do it right, you can change components inside, without paperwork. You just design it and certify it to cover all the bases before hand.

Steve

[slicklasers]

My understanding (which is quite likely wrong) is that a case is not certified. A completed projector is certified. Once a projector is certified, you can replace components (usually lasers) and then file a product update report. The upgrade report is just a couple of pages. In this way, a case is considered certified because it just takes an upgrade report to get variance on a projector made with the case.

Mike

You are correct, the case can only be Certified if it has all of the safety requirements, i.e, class 3B: remote interlock, time delay, and shutter, in class 4 you must have the remote interlock, housing interlock, time delay, shutter and a manual reset. I would sell my Varianced Slick Beam projectors with all safety requirements to anyone on here if they want. You could simply install your lasers and scanners and have a varianced projector.

[edison]

Great to see so many members are willing to participate to get it succed. But at this stage i,m not convinced about the safety items that are needed. Because i,m selling the case as a component and not as a complete projector there are some exceptions. I agree with Blowfly that only a complete projector can be certified. Blowfly, ledpaint , if you need info on the case let me know.



Johan

[slicklasers]

Great to see so many members are willing to participate to get it succed. But at this stage i,m not convinced about the safety items that are needed. Because i,m selling the case as a component and not as a complete projector there are some exceptions. I agree with Blowfly that only a complete projector can be certified. Blowfly, ledpaint , if you need info on the case let me know.



Johan

I could just make an ammendment to my projector variance and use your case. I already have a variance for manufacturing my own Slick Beam Laser Projectors, but I have my case built to order depending on what lasers are going into it... What is the cost to get one I could build a 1-3Watt in? If the price is right I will sell these to anyone on the forum that wants one and all they would have to do is drop in scanners and laser into it and they would have a certified projector... I would require that I did the wireing of the safety features so I would be certified....