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not correct. o-like is indeed in china.
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FrozenGate by Avery
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- Thread starter Mohrenberg
- Start date
Asherz
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I feel sorry for you, I hope you get everything sorted out ok and that this is taken any further than it already has been by the FDA, as already stated I guess you just got to comply with what the say.
I still am a little confused why there are people still saying you should just sell module etc, I would be more concerned about getting out of the position your in at the moment rather than worrying about how to sell more lasers.
Well I highly recommend you get a lawyer, I guess there are a few people on here that know kind of what there talking about but you need a proffesional to tell you exactly the best route of action, after first confirming the letter is real of course.
Well I wish you the best off luck and hope everything goes ok.
I still am a little confused why there are people still saying you should just sell module etc, I would be more concerned about getting out of the position your in at the moment rather than worrying about how to sell more lasers.
Well I highly recommend you get a lawyer, I guess there are a few people on here that know kind of what there talking about but you need a proffesional to tell you exactly the best route of action, after first confirming the letter is real of course.
Well I wish you the best off luck and hope everything goes ok.
Mr_Lazo
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That explains it. Thanks.
(I'm getting a mental image of a bunch of Chinese guys shining high output lasers over their shoulders while they drop trou at a bunch of oficious-type Americans -- thanks for that, too
)- Joined
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just a quick reply i would like to post here. i honestly didnt read every single post here, but i read most of them.
please see my comments.
1. Lasers in the USA are governed by specific rules and regulations. these are covered HERE.
2. Lasers that are brought into commerce in the USA (sold, imported, exported or USED) in the USA are REQUIRED BY LAW to meet minimum safety requirements set forth by the above CFR. (Code of Federal Regulation)
3. Briefly, these regulations and safety standards include but ARE NOT limited to:
A. delayed lasing of output after power is applied.
b. Key operated activation (Key CAN NOT be removed in the "ON" position)
c. Mechanical shutter of laser output. Either automatic OR human activated.
d. beam attenuation
e. PROPER labeling of laser. (i.e.- CLASS 3B laser output MAX. power output 600mW @532nm) label CAN NOT be broad and general. PROPER labeling requirements can be found HERE also. scroll down to see labeling requirements.
f. Date and location of manufacture
g. certification label.
AGAIN-
the above is NOT a complete list of what needs to be accomplished to have a "legal" laser system. it will give you an idea though.
Laser systems do not need to be "registered" per-se with the government. they have to be submitted with a product report which can be found HERE. the laser needs to prove that it meets the minimum requirements for safety. until that report is submitted AND APPROVED the laser system is NOT "LEGAL."
once it is approved, the laser system will get an accession number. (or variance as it is sometimes referred to).
now it is legal and eligible for resale. As long as the re-sale guidelines are met also.
laser modules, (NOT pointers or hand-helds) DO sometimes fall into a "gray area" as an OEM module becasue the laser system is sold as an intent to distribute to an end user which in trun will certify their END product as a certified and varianced laser projector. (or laser system.) Projector DOES NOT neccesarily mean a "laser light show projector."
FDA is SEVERELY and AGGRESSIVELY cracking down on high powered pointers. they are dangerous, being abused, not safe and are HIGHLY being used for criminal mischief which is making professionals REALLY pissed off in the laser community. 1 bad apple in the laser industry REALLY does make an impact on all of us. lasers are a VERY VERY small and highly publiciized industry.
oh, by the way...the letter you received is 110% LEGIT!! PLEASE, i repeat...PLEASE do not listen to a few of the "conspiracy theorists" here.
i will be more than happy to answer any questions any of you may have. As long as they are asked in a professional and respectful way. i do not need to get into a pissing match with anyone who is upset becasue they cant burn black electrical tape any more.
hope this helped a little bit.
please see my comments.
1. Lasers in the USA are governed by specific rules and regulations. these are covered HERE.
2. Lasers that are brought into commerce in the USA (sold, imported, exported or USED) in the USA are REQUIRED BY LAW to meet minimum safety requirements set forth by the above CFR. (Code of Federal Regulation)
3. Briefly, these regulations and safety standards include but ARE NOT limited to:
A. delayed lasing of output after power is applied.
b. Key operated activation (Key CAN NOT be removed in the "ON" position)
c. Mechanical shutter of laser output. Either automatic OR human activated.
d. beam attenuation
e. PROPER labeling of laser. (i.e.- CLASS 3B laser output MAX. power output 600mW @532nm) label CAN NOT be broad and general. PROPER labeling requirements can be found HERE also. scroll down to see labeling requirements.
f. Date and location of manufacture
g. certification label.
AGAIN-
the above is NOT a complete list of what needs to be accomplished to have a "legal" laser system. it will give you an idea though.
Laser systems do not need to be "registered" per-se with the government. they have to be submitted with a product report which can be found HERE. the laser needs to prove that it meets the minimum requirements for safety. until that report is submitted AND APPROVED the laser system is NOT "LEGAL."
once it is approved, the laser system will get an accession number. (or variance as it is sometimes referred to).
now it is legal and eligible for resale. As long as the re-sale guidelines are met also.
laser modules, (NOT pointers or hand-helds) DO sometimes fall into a "gray area" as an OEM module becasue the laser system is sold as an intent to distribute to an end user which in trun will certify their END product as a certified and varianced laser projector. (or laser system.) Projector DOES NOT neccesarily mean a "laser light show projector."
FDA is SEVERELY and AGGRESSIVELY cracking down on high powered pointers. they are dangerous, being abused, not safe and are HIGHLY being used for criminal mischief which is making professionals REALLY pissed off in the laser community. 1 bad apple in the laser industry REALLY does make an impact on all of us. lasers are a VERY VERY small and highly publiciized industry.
oh, by the way...the letter you received is 110% LEGIT!! PLEASE, i repeat...PLEASE do not listen to a few of the "conspiracy theorists" here.
i will be more than happy to answer any questions any of you may have. As long as they are asked in a professional and respectful way. i do not need to get into a pissing match with anyone who is upset becasue they cant burn black electrical tape any more.
hope this helped a little bit.
GooeyGus
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How can one get busted for selling mod chips... it's not like they're illegal, at least from what I know of them.
Now, pirated software/music/movies/anything else on CD/DVD, that's a big deal, but not an FDA thing... that's FBI or RIAA
- Joined
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because he had a website, and had received a warning from microsoft to cease and desist sales, yet he still continued, and after multiple more letters that he ignored, then they raided his home, arrested him, and charged him. and yes they are illegal according to microsoft, as they allow you to run your own codes and mod/cheat on xbox live. this was mostly for original xbox's
edit: sorry it was fbi.
edit: sorry it was fbi.
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Nope, I think you mean NOVA
GooeyGus
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ahhhh yeah ok that makes sense. If it allows you to cheat xbox live, which is a paid service, you can get into legal troubles.
There is a big grey area on the 'being able to play burned games' topic. One tends to immediately think it's illegal, but on the other hand every person has the right to make copies of ANYTHING for personal use.
GooeyGus
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jamilm9
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is this the number you called
(202) 530-4695
i googled him
http://findarticles.com/p/articles/mi_qa3890/is_200307/ai_n9255512/
(202) 530-4695
i googled him
http://findarticles.com/p/articles/mi_qa3890/is_200307/ai_n9255512/
Hi, I've been in this business a long time. Oh heck, I'm world famous. I signed up over here for just a few minutes. My username will ID me to many here, as I wrote a large amount of the chapters that Sam did not.
This thread came to my attention from another group.
For the record, I do not think there is any need at all for any nonvarienced entertainment laser or a laser pointer over 4.95 mW outside of your basement lab.. I hate high power pointers for the bad rap they have generated for the laser show community when IDIOTS aim them into airspace. That is why I will retreat after this post. I have been in the past held a variance and have submitted many product reports. I've done more professional laser work since 1988.
This is strictly for the aid of this fellow who has crossed paths with the CDRH. And to give many of you a heads up on how to avoid a letter like this.
One, an ordinary civil law lawyer will not be able to really help you effectively. Your into administrative law, and its a different animal then most lawyers practice. Also, do not go through this with out professional help. Your in deep trouble as you know.
1. There are 3 major outfits that can guide you through this, remember, law enforcement is not always required by law to tell the truth, so you need a consultant. You can be handed over to a US Attorney or you may find yourself given a fine without going to court, it depends on a lot of issues beyond your control. If I remember correctly it can be as bad as 250,000 or Six Months jail. I doubt you rate jail, but I am aware of one fellow that made laser power supply kits for henes who ended up with 20K in legal costs and a 8K fine.
This is by no means a complete list, however I have met Casey several times and I have met various Rockwell employees through ILDA, they are both world class.
Laser Compliance Inc Get in touch with Casey Stack.
He is a world class laser professional across a bunch of industries. http://www.lasercompliance.com/
Rockwell Industries
www.rli.com/
Laser Professionals Inc.
http://www.laser-professionals.com/home.php
You could expect a possible visit from a FDA specialist, they have a Federal badge and while they are not going to arrest you on the spot, it can be a grueling inspection. (I don't remember my local one ever having nor desiring arrest authority, nor did he carry or is authorized a firearm). He does wield a mean pen. What it will be, is a finding of fact sort of process. How to handle this possibility is between your lawyer, your consultant, the CDRH and you. I don't know how to advise you because I. I'm not a lawyer, and II. I've never been in violation. III I'm not a compliance specialist. I would not do anything stupid like dumping your gear or hide any paperwork you have. Federal administrative fines are supposed to be proportioned to the income of the person fined and the severity of the issue at hand.
2. Your going to be asked to submit some form of remediation plan. It may be anywhere from just cease and desist, to a recall from all your customers to pay a fine. If things don't go well, you get handed to a US Attorney for prosecution. This is why you need contact with a laser safety professional.
For laser shows in public you need a variance as a demonstration laser device. That is a whole different topic.
3. For the rest of the gentle readers here (apologies to Miss Manners) A good rule is if you are selling more then one of something or to more then one customer, your manufacturing.
Even a raw diode, a used diode, and certain parts such as collimation optics, barrels, laser diode drivers, laser show projectors, etc then YOU need to be registered as a manufacturer, by filing a "Manufacturer's Report" if your doing more then a few.
EBAY is a different can of worms, and can be a grey area.
There is no federal law preventing you from owning a kilowatt class laser in your basement. No law for transfering it to another American if you didn't manufacture it and am, only selling one. There are some state rules about registering lasers, like in Texas and Arizona and other states. But if you use it for making money, or in public, or export it, or expose your employees to it, then rules come into play.
For laser shows in public you need a variance as a demonstration laser device. That is a whole different topic.
The line really gets drawn at class IIIA, ie 4.95 mW or less.
Over that, its a safe bet you need a variance as well as manufacturers report filed if you make your own gear. No exceptions. What you do in your own basement is your business, but if you introduce anything over 4.95 mW to the public or outside your basement lab, its a whole new set of rules. FAA requires all pilots to report any laser they see, even if terminated, and lasers into airspace is a whole new can of worms, called FAA 7400. I've had pilots report shows I've worked on, even when a NOTAM is out for the show, and the FAA does check it out in real time, even if they need a local cop to do it. Even a legal pointer can interfere with a aircraft, JUST DONT DO IT.
Back to the manufacturers report:
Its actually quite easy, its free, and no where near the pain in the neck many people claim it is. The people that claim it is hard are lazy or don't want to request the data on how to do it from CDRH. CDRH is very proactive, they will NOT instantly tell you something like "You cant do that" if you call for help.
And they are not going to come visit you just because you called, unless you request a Regional Electro Optical Specialist to come see you.
I'm not going to go into a huge list of requirements, they are spelled out quite simply in a FDA publication. But... for a pointer, your probably talking two to four pages of text and drawings , if that much. And a simple checklist.
Like a medical device, you need to do quality control on your products, IE confirm as you make each device that it matches the checklist you submitted, and then 1 yearly report stating how many devices you sold, and if there were changes, deficiencies, returns, and what the power levels were, etc. You keep the records for 7 years, and if a EOS decides to visit you, you whip out your notebook with records and any correspondence you have received and your done. The recordkeeping is NOT to torture your customers, it is to protect them by allowing for a recall if the product is dangerous.
Its actually pretty painless if they visit you. If they find minor errors, you submit a correction report. NO BIG DEAL.
Oh, and yes, popping diodes out of old DVDs and reselling them is manufacturing.
Why is it the FDA that rules over lasers? My usual sarcastic remark is you would rather deal with the Nuclear Regulatory Commission or the ATF ? The answer is non ionizing radiation is in the FDAs area. The same division that handles lasers handles light sources, Xray, radio wave based medical devices etc. Since non ionizing radiation mainly affects tissue, its a medical thing and falls to the FDA. Lasers get treated as a simpler subset of the medical device rules, and hence the medical manufacturing report style and inspections and record keeping. Congress assigned non ionizing radiation to DHHS in the late 1960s.
One more thing, the myth that small lasers are not dangerous. CLASS II is based on the idea that your blink reflex will protect you. Class IIIA is based on the fact that hopefully powers under 4.95 mW will not harm you more then 1 time in 99,999 exposures. Medical aiming beams in the eye go up to about 3 mW, but if your eye doctor uses more then say .5, its damn painful. Most eye surgeons start to get real results at 150-200 mW, but can often see effects at 50 mW. Why risk exposing ANYONE with a powerful pointer or lab laser. Think about it, thats why the rules exist.
And they are ALL on the web these days, with many professional laser safety officers posting on thousands of sites.
I hope that clears up some issues.
Steve
This thread came to my attention from another group.
For the record, I do not think there is any need at all for any nonvarienced entertainment laser or a laser pointer over 4.95 mW outside of your basement lab.. I hate high power pointers for the bad rap they have generated for the laser show community when IDIOTS aim them into airspace. That is why I will retreat after this post. I have been in the past held a variance and have submitted many product reports. I've done more professional laser work since 1988.
This is strictly for the aid of this fellow who has crossed paths with the CDRH. And to give many of you a heads up on how to avoid a letter like this.
One, an ordinary civil law lawyer will not be able to really help you effectively. Your into administrative law, and its a different animal then most lawyers practice. Also, do not go through this with out professional help. Your in deep trouble as you know.
1. There are 3 major outfits that can guide you through this, remember, law enforcement is not always required by law to tell the truth, so you need a consultant. You can be handed over to a US Attorney or you may find yourself given a fine without going to court, it depends on a lot of issues beyond your control. If I remember correctly it can be as bad as 250,000 or Six Months jail. I doubt you rate jail, but I am aware of one fellow that made laser power supply kits for henes who ended up with 20K in legal costs and a 8K fine.
This is by no means a complete list, however I have met Casey several times and I have met various Rockwell employees through ILDA, they are both world class.
Laser Compliance Inc Get in touch with Casey Stack.
He is a world class laser professional across a bunch of industries. http://www.lasercompliance.com/
Rockwell Industries
www.rli.com/
Laser Professionals Inc.
http://www.laser-professionals.com/home.php
You could expect a possible visit from a FDA specialist, they have a Federal badge and while they are not going to arrest you on the spot, it can be a grueling inspection. (I don't remember my local one ever having nor desiring arrest authority, nor did he carry or is authorized a firearm). He does wield a mean pen. What it will be, is a finding of fact sort of process. How to handle this possibility is between your lawyer, your consultant, the CDRH and you. I don't know how to advise you because I. I'm not a lawyer, and II. I've never been in violation. III I'm not a compliance specialist. I would not do anything stupid like dumping your gear or hide any paperwork you have. Federal administrative fines are supposed to be proportioned to the income of the person fined and the severity of the issue at hand.
2. Your going to be asked to submit some form of remediation plan. It may be anywhere from just cease and desist, to a recall from all your customers to pay a fine. If things don't go well, you get handed to a US Attorney for prosecution. This is why you need contact with a laser safety professional.
For laser shows in public you need a variance as a demonstration laser device. That is a whole different topic.
3. For the rest of the gentle readers here (apologies to Miss Manners) A good rule is if you are selling more then one of something or to more then one customer, your manufacturing.
Even a raw diode, a used diode, and certain parts such as collimation optics, barrels, laser diode drivers, laser show projectors, etc then YOU need to be registered as a manufacturer, by filing a "Manufacturer's Report" if your doing more then a few.
EBAY is a different can of worms, and can be a grey area.
There is no federal law preventing you from owning a kilowatt class laser in your basement. No law for transfering it to another American if you didn't manufacture it and am, only selling one. There are some state rules about registering lasers, like in Texas and Arizona and other states. But if you use it for making money, or in public, or export it, or expose your employees to it, then rules come into play.
For laser shows in public you need a variance as a demonstration laser device. That is a whole different topic.
The line really gets drawn at class IIIA, ie 4.95 mW or less.
Over that, its a safe bet you need a variance as well as manufacturers report filed if you make your own gear. No exceptions. What you do in your own basement is your business, but if you introduce anything over 4.95 mW to the public or outside your basement lab, its a whole new set of rules. FAA requires all pilots to report any laser they see, even if terminated, and lasers into airspace is a whole new can of worms, called FAA 7400. I've had pilots report shows I've worked on, even when a NOTAM is out for the show, and the FAA does check it out in real time, even if they need a local cop to do it. Even a legal pointer can interfere with a aircraft, JUST DONT DO IT.
Back to the manufacturers report:
Its actually quite easy, its free, and no where near the pain in the neck many people claim it is. The people that claim it is hard are lazy or don't want to request the data on how to do it from CDRH. CDRH is very proactive, they will NOT instantly tell you something like "You cant do that" if you call for help.
And they are not going to come visit you just because you called, unless you request a Regional Electro Optical Specialist to come see you.
I'm not going to go into a huge list of requirements, they are spelled out quite simply in a FDA publication. But... for a pointer, your probably talking two to four pages of text and drawings , if that much. And a simple checklist.
Like a medical device, you need to do quality control on your products, IE confirm as you make each device that it matches the checklist you submitted, and then 1 yearly report stating how many devices you sold, and if there were changes, deficiencies, returns, and what the power levels were, etc. You keep the records for 7 years, and if a EOS decides to visit you, you whip out your notebook with records and any correspondence you have received and your done. The recordkeeping is NOT to torture your customers, it is to protect them by allowing for a recall if the product is dangerous.
Its actually pretty painless if they visit you. If they find minor errors, you submit a correction report. NO BIG DEAL.
Oh, and yes, popping diodes out of old DVDs and reselling them is manufacturing.
Why is it the FDA that rules over lasers? My usual sarcastic remark is you would rather deal with the Nuclear Regulatory Commission or the ATF ? The answer is non ionizing radiation is in the FDAs area. The same division that handles lasers handles light sources, Xray, radio wave based medical devices etc. Since non ionizing radiation mainly affects tissue, its a medical thing and falls to the FDA. Lasers get treated as a simpler subset of the medical device rules, and hence the medical manufacturing report style and inspections and record keeping. Congress assigned non ionizing radiation to DHHS in the late 1960s.
One more thing, the myth that small lasers are not dangerous. CLASS II is based on the idea that your blink reflex will protect you. Class IIIA is based on the fact that hopefully powers under 4.95 mW will not harm you more then 1 time in 99,999 exposures. Medical aiming beams in the eye go up to about 3 mW, but if your eye doctor uses more then say .5, its damn painful. Most eye surgeons start to get real results at 150-200 mW, but can often see effects at 50 mW. Why risk exposing ANYONE with a powerful pointer or lab laser. Think about it, thats why the rules exist.
And they are ALL on the web these days, with many professional laser safety officers posting on thousands of sites.
I hope that clears up some issues.
Steve
- Joined
- Sep 20, 2008
- Messages
- 17,635
- Points
- 113
Nice to see you here Steve... very well explained in layman's terms...
This should clear up the ambiguity that's been posted on this
and other similar threads...
This post should be stickied...
in the "Should be aware of or Should Know" section...IMO..
Jerry
This should clear up the ambiguity that's been posted on this
and other similar threads...
This post should be stickied...
in the "Should be aware of or Should Know" section...IMO..
Jerry
- Joined
- Jan 2, 2009
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- 11,800
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- 0
I agree. There are so many people here talking out of their ass, and getting blue in the face about. I'll never understand that.
These facts are good to know, and should be stickied, but without the hoopla. All the best of luck to you Matt.
- Joined
- Feb 28, 2008
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While I do feel badly for OP here, I'm glad someone has pointed out the regulations with regard to selling high powered lasers. The FDA can't stop you from selling lasers over 5mw as long as they meet these regulations, among other things noted above. It's not the power of the lasers as much as the required safety features that they lacked.
And yes, every so often you do run into a government employee who wants to throw his/her weight around and be a jerk. I'll never forget the time when I was a licensed taxidermist and I had to allow the state Department of Natural Resources to inspect my work shop and any other areas related to my business every year. There was one DNR officer who seemed to want to do everything in his power to bust me, and was just looking for something to "catch" me on. He never did come up with enough to bust me, though there were a couple of things in my record keeping that weren't completed as they should be. I corrected these things but he was still as nasty as could be and out to bust me, so after the second time he came around to inspect my shop I'd had enough and I wrote a letter to his supervisor. Well, that did the trick as I never saw him ever again!
I'm not suggesting that you would get anywhere to go above this FDA guy to his superior, but in my case it did help. I still had officers come around for the yearly inspection, but at least I got ones that weren't jerks and didn't nit-pick.
Unfortunately this tends to be the cost of doing business if you are in a business where your products are subject to state or federal regulations.
But with lasers, I can see where this sort of thing is cost-prohibitive to implement - all the safety features will add to the cost of the finished product, which is why the legal (like LaserGlow) pointers are much more expensive than the illegal ones from China.
Of course, just because a pointer has all these FDA compliant features and is legal to sell, that won't stop some idiot from pointing it at an aircraft...
And yes, every so often you do run into a government employee who wants to throw his/her weight around and be a jerk. I'll never forget the time when I was a licensed taxidermist and I had to allow the state Department of Natural Resources to inspect my work shop and any other areas related to my business every year. There was one DNR officer who seemed to want to do everything in his power to bust me, and was just looking for something to "catch" me on. He never did come up with enough to bust me, though there were a couple of things in my record keeping that weren't completed as they should be. I corrected these things but he was still as nasty as could be and out to bust me, so after the second time he came around to inspect my shop I'd had enough and I wrote a letter to his supervisor. Well, that did the trick as I never saw him ever again!
I'm not suggesting that you would get anywhere to go above this FDA guy to his superior, but in my case it did help. I still had officers come around for the yearly inspection, but at least I got ones that weren't jerks and didn't nit-pick.
Unfortunately this tends to be the cost of doing business if you are in a business where your products are subject to state or federal regulations.
But with lasers, I can see where this sort of thing is cost-prohibitive to implement - all the safety features will add to the cost of the finished product, which is why the legal (like LaserGlow) pointers are much more expensive than the illegal ones from China.
Of course, just because a pointer has all these FDA compliant features and is legal to sell, that won't stop some idiot from pointing it at an aircraft...
- Joined
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I have a better Idea
Gottaluvlasers and Steves post should have to be read and then a little box clicked that says "I have read and understand the the above post and agree to abide by the laws set forth of this land and agree never to talk out my ass and give advise on anything that I am not 100% sure about"
BEFORE YOU ARE TO LOG IN EACH TIME
I have seen some REAL BAD ADVISE being tossed around here from people who are for lack of a better word.....CLUELESS.
Gottaluvlasers and Steves post should have to be read and then a little box clicked that says "I have read and understand the the above post and agree to abide by the laws set forth of this land and agree never to talk out my ass and give advise on anything that I am not 100% sure about"
BEFORE YOU ARE TO LOG IN EACH TIME
I have seen some REAL BAD ADVISE being tossed around here from people who are for lack of a better word.....CLUELESS.
- Joined
- Dec 27, 2008
- Messages
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- 0
In reference to everyone jumping on the "he was a jerk and rude and unprofessional" bandwagon.
I call bullshit...keep in mind you only heard one side of the conversation. Or at least one side of the REPORTED CONVERSATION, am I calling MOH a liar? not exactly but I wasnt part of the conversation and frankly my conversations with MOH have been less than stellar. He has a cocky side of him that makes me look like Mother Teresa.
My guess is he was stern and professional, Dan has been around the block more than once.
Sorry I had to say that but cant take it back now...I have already hit the "submit reply" button
I call bullshit...keep in mind you only heard one side of the conversation. Or at least one side of the REPORTED CONVERSATION, am I calling MOH a liar? not exactly but I wasnt part of the conversation and frankly my conversations with MOH have been less than stellar. He has a cocky side of him that makes me look like Mother Teresa.
My guess is he was stern and professional, Dan has been around the block more than once.
Sorry I had to say that but cant take it back now...I have already hit the "submit reply" button
