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Old 11-27-2011, 07:06 PM #1
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Default FDA Compliant importers

I am new to lasers...in my fourties. Left a long time career to pursue a career doing what I want to do. Been burned in the learning process by importers who claim to be FDA compliant. Anyone know wholesale importers who are FDA compliant? OR...even better ones in the USA who are reasonably priced? I'm interested in showlasers up to 1W. Thanks!


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Old 11-28-2011, 09:55 PM #2
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Default Re: FDA Compliant importers

There is a new maker in USA about to start sellling MADE IN USA RGB projectors- cannot at this time tell you more until he gives me the go-ahead.


where are you located- plz put that in your profile page so it shows every time you post,... helps a lot to give you better info, and there may be a vet member near you so you can get with them for EZ help- welcome to the forums---hak

ps

you could build you own from parts- saves you a lot of money- you learn to fix it yourself and the build gives great satisfaction. Cost to do this now is significantly lower than ever before- two years ago building a RGB would have cost you much more than today.

Also occasionly good used items get put up on the BS&T section and you would be wise to also join Photolexicon lasser forum as PJs are thier main concern- lots of help there and sometimes good ones for sale.. GL



ALSO plz make a new thread in the WELCOME section telling a little about yourself-- an introduction is always a good move. Most do that.

I will give your name to my projector building USA buddy.
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Old 11-28-2011, 10:23 PM #3
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Default Re: FDA Compliant importers

Thanks Hak...lots of good advice. Already did a brief edit on my profile. Sorry about that...my first forum.

I'd def be into learning to build my own. As it is right now, ive been able to purchase a couple of imports using my business to get 'em at wholesale. Only to learn that they are not FDA compliant, but rather they have only filed...not approved. I got a couple great deals...one is crap the other isnt to bad...as far as I can tell (nothing to compare it to) I was thinking of getting a Megalase from Gtech.

I'll see how this goes and then join PL if it seems to be something I keep up on.

Thanks again

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Old 11-28-2011, 10:50 PM #4
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Default Re: FDA Compliant importers

Quote:
Originally Posted by hakzaw1 View Post
There is a new maker in USA about to start sellling MADE IN USA RGB projectors-
There might be more than one.

And foxtrot.. There really isn't such thing as 'FDA approval'. Approval from them consists of never hearing anything more from them after you file for and receive an accession number. You only hear more from them if there's something about your application, or your product.. that they don't like.
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Old 11-28-2011, 11:38 PM #5
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Default Re: FDA Compliant importers

How about just modifying the products received to make them compliant ?
Add the safety features, complete measurements of outputs, etc.
If someone can get their home-made rig compliant then modifying one of those cheapy ones can't be all that bad can it ?
(I think I have read some threads about it here or over on PL.)
In the end it will probably cost about the same as if you purchased locally but you would be using the items already paid for.
Just a thought...
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Old 11-28-2011, 11:51 PM #6
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Default Re: FDA Compliant importers

Thanks all...I thought the product had to be deemed compliant by the FDA...so, it is legal to purchase from those companies who have attained an accesion letter. Good to know...i think one of mine is okay. I still need to apply for the variance.

Anybody have thoughts on good compaines to buy from? Then I need help with cheap ILDA software. :-) u guys are in trouble now.

FYI- its great to be talking with people who know...it's been a rather frustrateing ride not knowing anyone or having any local resources.--tks!!!!
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Old 11-29-2011, 12:06 AM #7
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Default Re: FDA Compliant importers

For projectors under or around 1W I would definitely check out X-Lasers.com....they are a Member on PL and are probably the ONLY legal importer of cheaper projectors.....They will apply for your variance and get you 100% compliant and legal.....
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Old 11-29-2011, 12:22 AM #8
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Default Re: FDA Compliant importers

I recommend LSX from dr.lava as far as software goes. http://hacylon.case.edu/ebay/laser_diode/LSX.php

On the FDA standpoint, the way it works, in a nutshell, is this; You submit your product design, etc, and your application to the FDA and they give you an accession number. Your then allowed to sell your product once you receive your accession number, however, you are required to keep records each and every product sold. When the FDA actually gets around to reviewing your application an product in detail, and they find something they don't like about it, or if what your selling doesn't match what was submitted, you get a notice of non-compliance.. If you get one of those, you have to do everything in your power to recall and fix each and every laser device you sold under that accession number and correct the deficiencies they found. If you don't, the accession number gets pulled.

Like I said. if you never hear from the FDA after you get your accession number, that's pretty much an approval. You only hear from them when there's a problem.

Also, since accession numbers are by product.. and not by company.. An easy way to find out if a chinese company (or anyone else) is lying about having gone through the process is to ask for the accession numbers for two vastly different laser products they sell. If they give you the same number for both.. they're lying.


It's not really hard to get an accession number. However the costs if a problem is found mount up drastically.. which is why you have to make sure your ducks are in a row on the front end.. which is the real hard part of getting an accession number. And why most chinese sellers don't actually have one, or have one for a limited time until they get notified of non-compliance and do nothing about it and get the number pulled.
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Old 11-29-2011, 12:30 AM #9
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Default Re: FDA Compliant importers

Thanks KGB...i know of X-laser...but have no idea of their pricing...i bet they're not cheap. I'll prob start to build my own. I just can shell out thousands of dollars to buy one in the states. What are "pro wides"?
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Old 11-29-2011, 12:33 AM #10
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Default Re: FDA Compliant importers

pro wides are galvo's.. the mirrors and motors that actually scan the beam.
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Old 11-29-2011, 12:38 AM #11
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Default Re: FDA Compliant importers

Right o Fox...thanks. That makes sense...well, kind of. So if you are using them for personal use, buying from another country is not such a big deal. If you intend to use them in public...get the variance.
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Old 11-29-2011, 12:48 AM #12
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Default Re: FDA Compliant importers

Variances and accession numbers are two different things. heh. Technically you need variance for any 'public demonstration'.. which basically means.. anybody other than yourself according to how the rules are actually written.

In practice, so long as your not using it where 'the general public' has access, most of the time nobody will say anything. Showing your buddies in a room in your house with the blinds closed.. Fine generally (as long as your not being stupid, but that's a safety issue) Having a big party with a bunch of people and having it going... you should have a variance for that.

With the FDA thing.. Unless your abusing a laser somehow(i.e illuminating cars, people and aircraft).. your not going to have 'the law' beating on your door just for buying a non approved laser.. You just run the risk of customs seizing it if your importing it. The FDA goes after sellers, not buyers.

The variance side is what the buyers have to deal with, and again. usually isn't an issue unless your attracting attention to yourself.
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Old 11-29-2011, 01:08 AM #13
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Default Re: FDA Compliant importers

Got it...i should have said it better. Thanks for the clarification though.

Say I buy a laser from Germany. All of it complies to the FDA guidlines. I buy it (no paperwork on their side or mine)...learn my software and then want to do a party (for pay)...I can now apply for the variance for this one event...correct? As long as the unit is in compliance, I shouldn't have a problem. And yes...i'm very familiar with all the safety guidelines...including (unforunatly) crowd scanning.

I cant seem to find LSX or Dr. Lava...any help here? Another 100 bucks and im now in the range for Mamba, Pheonix or Quickshow. Should I just wait and go with one of them? My goal is to do very detailed, multi-projector shows to music...ive heard that Quickshow is better for DJ type improvised stuff...lots of stock images/scenes on the fly. Is iShow garbage? Must be...looks like it anyway.

Thanks again...this is AWESOME.!!! BY the way, this is an addiction. With each laser...all I want is a faster scanner and higher power.

OH man...one more question...the 1W Blue 450nM i purchased from Asia has what I think is a rather fat beam diameter, Is this something that I can adjust...with the right guidance?

Thanks once again.
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Old 11-29-2011, 01:38 AM #14
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Default Re: FDA Compliant importers

I posted a link to LSX in the post where I mentioned the software.

Heh the safety guidelines for crowd scanning in the US are pretty simple.. Don't do it. Technically you can but the MPE restrictions make it not worth it.

If your wanting a DJ rig, LSX might not be the best choice for software even though it's perfectly capable of doing what is needed. Though it really depends on if your trying to do a bunch of stuff by yourself or not.. I.e.. trying to be the dj.. the sound guy, AND the lighting guy all at the same time. I think quickshow is probably geared more towards 'just pushing buttons' though LSX will give you much more dynamic live shows if you take the time to learn the software and what it can do. Especially all the modulation functions, etc.

As far as the 1W 450nm.. It's more than likely 445nm. And these are multimode. If your laser outputs a line, it doesn't have corrective optics and corrective optics might help the problem.. If it outputs a relatively symmetric square, it's already about as good as it can get.
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Old 11-29-2011, 02:22 AM #15
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Default Re: FDA Compliant importers

The beam pont appears to be a line or like a marker tip when cast on a surface...i dont know the dipswitch code for maintainance, but the beam appears to be about 1/8" leaving the apperature.

How do I find out what addditional I need with my LSX software? It looks as if the Lite comes with what you need but then askes about Dongles and Riya Dac's...both of which I'm clueless about.. Am I correct...$150?? I have an Enttec Open which got me seeing beams and my initial introduction to DMX with Freestyler. SLX sounds like the perfect software for what I want to do. Can you control DMX (non ILDA) and IDLA units through the same software?

Thanks for taking the time. I'll try not to follow up with another question. Sorry.
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And then: a 800mW 4 beam RG B Y
Who knows after that!!!!
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Old 11-29-2011, 02:57 AM #16
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Default Re: FDA Compliant importers

Sounds like your laser doesn't have corrective optics then. Just a modulated 445 diode. Hope you didn't give a huge some for it. DIY you can build about the same thing for around $100-$150 depending on heatsink and housing choices.

You should read this thread on PL for more info about LSX. Announcement: New laser show software available: Procedural dynamic frames, Much More

The dongle/dac thing is just for copy protection. He offers enough options to make this not a problem, and unlike some laser software, LSX isn't tied to any particular computer for eternity. Dr.Lava actually doesn't care how many you install it on, but each machine you put it on still needs to be registered through him. It's free but sometimes it takes a day or two for him to reply back with the reg keys. Though LSX will only run when the dongle (which ever one you go with) is connected to that particular machine.

For instance I have it installed on my desktop here, as well as my laptop, and is keyed to my RIYA DAC. So while it's installed on both, it'll only run on whichever one the DAC is plugged in.

If you already have a DAC, and it's not a QM card, and you don't already have a LDS dongle, Getting the USB dongle is your best option probably. When I bought it, I didn't have a DAC so I went ahead and got a RIYA DAC from him at the same time, and the software is keyed to that.
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Last edited by qumefox; 11-29-2011 at 03:00 AM.
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