FDA approval

[edison]

As some people have noticed i,m organize a group for some PL members.

Ledpaint wanted to get his case FDA approved. I think he has a point so i,m willing to try to get FDA aproval on my cases in the future so that more USA members willing to use my case. If anyone have experiance with getting the FDA aproval or possibly point me in the right direction that would be great

Thanks guys

[dsli_jon]

Hey Edison -

If anyone have experiance with getting the FDA aproval or possibly point me in the right direction that would be great

I could help, if I wasn't so dern busy! So, I'd suggest contacting Casey Stack, at Laser Compliance - THE Top Man when it comes to the Regs, here, and can get you hooked-up with the correct info in a snap. I won't tell you he's 'cheap' - but his pricing is very 'fair' for the expertise you get - anything worth doing (and your endeavour is.. is worth doing RIGHT (and your endeavour is and worth paying the expert-help for it TO-BE right... The old cliche IS one, because it's TRUE: 'you get what you pay-for'...

If 'L.C.', there, is too 'backed-up' or anything, you could also contact PL Member 'One Stop Laser Shop', and ask Fred or Amanda if they'd be willing to help... they have gone thru the 'process' and sell a nice certified housing, here, in the US... but I know Casey, et al, have the 'total picture' covered, from an International-Regs perspective, as well... This is why I recommend Casey first and formost...

Hope this helps...
cheers..
J

[ElektroFreak]

So is there anywhere that sells FDA certified cases that aren't over 2 grand? I find that price for an empty case to be repulsive and bordering on the side of extortion. I'd pay up to $1,000 TOPS for a decent, SMALL case.. I can't see for a second why that can't be done.

I really feel sometimes that this whole "legal pro" game is carefully set up to discourage new people from entering the business without putting their family's fiscal security at risk. Very nice way to keep a lid on the profession. One day I'd like to start a small company here, but I just can't afford to put my family at risk by taking out a loan so I can get cases. That's not even talking about the rest of the projectors' parts.. It's kind of discouraging, really, and I see NO reason for the excessive cost. None at all. I understand safety, but from what I understand of this process, unless you have upwards of $10,000 JUST FOR FDA APPROVAL... you're not doing shit in this country... but NOO.. it's not an old boys club, is it? And people sometimes seem surprised about the illegal shows being done here...

We're not all trying to do stadium shows.. there is a market for lots of smaller events, but given the cost of a lot of this process it's not worth it if you're not doing HUGE shows.

[/rant]

Perhaps the preceding rant and this question are due to my relative lack of understanding, but it is theoretically possible to build a case and design a system and have it approved without paying any third party, is it not?

[dsli_jon]

Hey EF -

I find that price for an empty case to be repulsive and bordering on the side of extortion. I'd pay up to $1,000 TOPS for a decent, SMALL case.. I can't see for a second why that can't be done.

There are certainly others that sell smaller enclosures for less - if you're 'ranting' about the 'OSLS LT-1000 / LT-500' (f.k.a. LasVegas Lasers LT-1000 / 500...) well, those are fairly large cases - and a good bit of work to machine / put together, from scratch... then Certify...

What I'd - respectfully - suggest is: Go build your own - design a box, machine it up, go thru the entire process / get it Certified - and then come back and let us know how much below $2K you'd be willing to sell it for....

I'm not arguing your 'sense of frustration with costs', but I'm pretty-sure it has far-more to do with what was invested in the first place (and certainly, SOME portion of the cost for materials / machining, etc...) plus - any *potential* liability, that might come back to 'haunt' - IF someone were, for example, blind someone at a gig with a 'certified' projector, the manufacturer / certifier would likely have to hire a $$$tinking lawyer to supply, conclusively, the 'burden of proof' that they, in no way, could-be liable - and all that cost - despite having NOTHING to-do with the actual 'cause' of the problem, (the operator) in that case...

Yes, this does not happen 'often' - maybe never - but these are things that a 'commercial manufacturer' of (potentially) mass-distributed projectors has to think about....

So, again - respectfully - go 'DIY' that all and see if you feel like selling those at $1K / how TRULY profitable it was / is for you...

I really feel sometimes that this whole "legal pro" game is carefully set up to discourage new people from entering the business...... but NOO.. it's not an old boys club, is it? And people sometimes seem surprised about the illegal shows being done here...

We're not all trying to do stadium shows.. there is a market for lots of smaller events, but given the cost of a lot of this process it's not worth it if you're not doing HUGE shows.

Again - respectfully - I feel 'I can open my mouth' cause I can speak from the perspective of a person who started out EXACTLY as everyone here - in his basement / garage - and in many ways, from MUCH LESS of an advantage-point, as many of the members, here - I was NOT an 'electrical engineer ' / DID not have access to university / huge laser co's surplus bins (ok, I got a few goodies from Kodak surplus, - whoopdie-doo...NOTHING like the 'scrap' / surplus that LaserBen and others find / come across - and 'eBay' did not even exist yet, when I started...) - I had to 'climb the mountain' the hard way.. all by myself, asking questions, reading books, trial and error, trial and error, then - trial and better...

I'm not trying to 'play some violin', here, just saying that I, for one, am GLAD that the TRUE Pro stuff IS so expensive, cause #1, I think to achive getting that stuff (unless you're a spoiled-brat 'prodj-type' with a rich daddy, etc) the blood-sweat and tears you put in, encourages a sense of responsibility - fosters an attitude of 'doing things right' / safe - etc, etc - it is the 'rich hacks' and those that get cheap / illegal chinese-crap out there, that are the ones doing illegal / unsafe and cut-throat shows, and that have tanked the industry - if you spend 40-50 hours designing / building a show - WHY SHOULD YOU NOT get $10K for it??? Correspondingly, if you spend 4-5 MONTHS designing / certifying a box - WHY SHOULD YOU NOT get $2K for it???

#2 - I think the stuff being expensive 'curbs', at-least - every laser-pointer-totin-weedhopper FROM getting Class IIIb / IV stuff and becoming a menace to the Industry - can you imagine the laser show market if it was any easier to get illegal Class IIIb / IV crap out there / start hacking the local market??

And I think you'd feel 'differently' about it if you were already making a living at it - you'd not be so-much opposed to 'legitimate' Co's coming up, those operating LEGALLY, and UPHOLDING good- pricing in the industry, as you would-be to those operating ILLEGALLY, and cutthroatting on price - and then, doing crap / ho-hum work, so that the Client never wants to hear the word 'laser' again... THAT is what the 'cheaper' stuff tends to 'encourage', IMO....

So, again, all due-respect to your feelings, I think the 'worth it' has to be looked at, longer-term - if you wanna 'support a family' doing laser shows - yep, you better be independantly wealthy, or plan on it being 5-10 years MIN to profitability.... If you're just doing 'occasional' / non-stadium shows, well, you might consider it 'wiser' to just put that $2K towards a COMPLETE system, already Certified, and focus your $$ on marketing / advertising your sales-efforts, rather than the 'ultimate / cheapest-way' to build...

Yeah, I know - it's a steep climb - but it is what it is... I, for one, am glad I have 'something to strive-for'....

...Discuss...
peace
j

Oh - PS -

Perhaps the preceding rant and this question are due to my relative lack of understanding, but it is theoretically possible to build a case and design a system and have it approved without paying any third party, is it not?

ABSOLUTELY YOU CAN!! But again - I humbly submit that when you get done going thru all that - it is a process - you won't find $2400. to be all-that 'unreasonable'... especially if people were then-buying YOUR Certified boxes...

peace..
j

[-=Jim=-]

I have to agree with Jon here I have built my own cases and found to do it right it's going to cost almost as much as the LT1000. In fact the last case I built built I was real happy with and probably spent $900.00 on it now sits in my scrap aluminum pile. It has since been replaced with an LT1000.

I also have to say that the LT1000 is more than an aluminum box. The product is quite well engineered I can blow the entire case apart in minutes to get at anything inside and reassemble it in 5 minutes.

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.

[blowfly]

Hey Edison, I fully intend to get variance with the projector I'm building with your case. I have spoken a bit with Roberta here on the forum who has a lot of experience and said she could look over my plans and FDA documentation for a fair fee. I've read through the FDA paperwork a few times and I don't foresee the whole process as being terribly difficult, just perhaps a little time consuming. I've also looked at some completed and approved documentation.

However we end up going about this, we should combine our efforts since we're certifying the same case!

Mike

[ElektroFreak]

Hmm. Sounds like the voice of experience from both of you. I relish DIY, so the idea of designing, building and getting the case certified really doesn't sound terrible (I say that now, never having done it..). For the sake of the thread topic and my curiosity, is there a checklist of sorts covering what is necessary for certification? I'm referring to the case only. If it's just four walls and some interior structural elements, an aperture and a case interlock switch, I'm not really seeing what the big deal is other than filling out paperwork..

[LEDpaint]

Blowfly,

I'm willing to kick in a bit. Let me know what you need.

[Synce]

Hey Edison, I fully intend to get variance with the projector I'm building with your case. I have spoken a bit with Roberta here on the forum who has a lot of experience and said she could look over my plans and FDA documentation for a fair fee. I've read through the FDA paperwork a few times and I don't foresee the whole process as being terribly difficult, just perhaps a little time consuming. I've also looked at some completed and approved documentation.

However we end up going about this, we should combine our efforts since we're certifying the same case!

Mike

Since I will also be getting a case from Edison, I'd be willing to help as well!

[edison]

Thanks guys

I like to team op with some members here to get the case certified. However i can imagine that if something has to be changed in the design i simply can,t do this for the ones from the groupbuy because manufacturing starts within 1 week from now. The struths are being cut this week.
Thanks for sharing me the link from laser compliance J thats a great help. I also will contact FDA to provide me the paperwork and see if it is difficult. However when it comes to the money aspect i really don,t give a shit about money. Money is just something you need to get somewhere, i spend thousands of euro,s to a trip arround New zealland. Its all gone but the memory and pictures are wort every penny.
You could die tommorow and have a million dollars on your account and you had the chance of helping people how stupid is that. As long as i can buy a martini-bitterlemon i,m fine

I like lasers and helping PL members and other USA members to get them a case to do lasershows as safe as possible. I also designed a connectionboard for making it easy to connecting a scanfail between scanneramps and drivers. If people buy it i can convince to buy the scanfailure if they are building their own laserprojector. I,m building it for a customer i dont sell it any projector without it. period. I think safety is very important so the more members are implement scanfailures in their projector the better. Audiance scanning or not.