diachi
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Contacted by the FDA, basically told to cease and desist.
That's why Survival Lasers has a US specific site and an international site.
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looking for a high quality laser my first
- Thread starter razklowd1
- Start date
Contacted by the FDA, basically told to cease and desist.
That's why Survival Lasers has a US specific site and an international site.
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c r a p
That would freak me out.
I'm just curious are there any threads you know of about this happening that I could read, seems interesting. But I doubt it went public?
Laser Pointer Safety - Laser rules and regulations for U.S. consumers
"Under federal law, it is perfectly legal to sell any laser above 5 mW as long as the laser complies with FDA/CDRH laser product requirements for labels, safety features, quality control, etc. AND as long as the laser is not promoted as a “laser pointer” or for pointing purposes.
If a laser over 5 mW is called a “pointer” or is sold for pointing purposes, the person doing the illegal action is the manufacturer or seller. If the consumer (end user) has a mislabeled or non-compliant laser, it is legal for them to possess it. We are unaware of any cases where a non-compliant consumer laser has been taken from its owner simply for being mislabeled or because it did not have the safety features of its class."
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FDA's up to date definitions have it all covered from several directions/angles --it doesn't matter what you call it "pointer" or "demonstration laser" either which way if it is over 5mW is prohibited from importation into the USA and for sale as an item of commerce from within USA to within the USA. It doesn't matter if is an unassembled kit either as long as the kit can make a complete lasers --all kits must meet the same regulations as fully assembled laser when they are assembled----thus Survival had to stop selling them and several others also.
From the FDA web site:
"What is a laser pointer?
Laser pointers are hand-held lasers that are promoted for pointing out objects or locations. Such laser products can meet one of two definitions for laser products. The first is for “surveying, leveling, and alignment laser products” as defined by Title 21 of the Code of Federal Regulations (CFR) Section 1040.10(b)(39):
“Surveying, leveling, or alignment laser product means a laser product manufactured, designed, intended or promoted for one or more of the following uses:
(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another.
(iii) Defining a plane, level, elevation, or straight line.”
Hand-held lasers promoted for entertainment purposes or amusement also meet the second definition, that of “demonstration laser products” as defined by 21 CFR 1040.10(b)(13):
“Demonstration laser product means a laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.”
Lasers promoted for entertainment purposes or amusement also meet FDA’s definition for “demonstration laser products.”
Laser products promoted for demonstration purposes are limited to hazard Class IIIa by FDA regulation 21 CFR 1040.11(c). This means that pointers are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers.
Does FDA have a mandatory limit on the power emitted by laser pointers?
Yes. Laser products promoted for pointing and demonstration purposes are limited to hazard Class IIIa by FDA regulation.
From the FDA web site:
"What is a laser pointer?
Laser pointers are hand-held lasers that are promoted for pointing out objects or locations. Such laser products can meet one of two definitions for laser products. The first is for “surveying, leveling, and alignment laser products” as defined by Title 21 of the Code of Federal Regulations (CFR) Section 1040.10(b)(39):
“Surveying, leveling, or alignment laser product means a laser product manufactured, designed, intended or promoted for one or more of the following uses:
(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.
(ii) Positioning or adjusting parts in proper relation to one another.
(iii) Defining a plane, level, elevation, or straight line.”
Hand-held lasers promoted for entertainment purposes or amusement also meet the second definition, that of “demonstration laser products” as defined by 21 CFR 1040.10(b)(13):
“Demonstration laser product means a laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.”
Lasers promoted for entertainment purposes or amusement also meet FDA’s definition for “demonstration laser products.”
Laser products promoted for demonstration purposes are limited to hazard Class IIIa by FDA regulation 21 CFR 1040.11(c). This means that pointers are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers.
Does FDA have a mandatory limit on the power emitted by laser pointers?
Yes. Laser products promoted for pointing and demonstration purposes are limited to hazard Class IIIa by FDA regulation.
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diachi
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Nailed it!
@Crazlaser - you can sell your 1W 445 as a "portable laser" all you want, but if it's in a battery powered host it's obvious what the intent is. Especially if the page has things like "COOL BURNING LASER, LIGHTS MATCHES!!" and stuff like that.
The FDA aren't dumb...
Looks like it!
Razako
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I sincerely doubt that the FDA care to track down individuals selling on this forum. Unless you make a business of it, you should be fine. Even if you do make a business of it, they seldom seem to care. Plenty of ebay sellers based in the US selling >5mw pointers.
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diachi
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Yeah ... it's just something to keep in mind. Definitely increased risk if you make a business of it. :beer:
From FDA web site:
"FDA regulates all laser products, even handheld, battery-powered lasers that are available for purchase FROM manufacturers, importers, assemblers, dealers or distributors in the United States and its territories. This includes lasers manufactured or obtained on a continuing basis for the purpose of sale or resale.
FDA requires that manufacturers of these lasers limit the power of the laser light to 5 milliWatts (often abbreviated as "mW") or less. The labeling or packaging must allow the purchaser to know the power of the laser, its hazard class, and its wavelength before the laser is purchased. Even online advertisements must display this information for the purchaser.
Even the smallest handheld, battery-powered lasers are capable of emitting laser light at hazardous powers. Larger models, the size of a small flashlight, can burn skin and pop balloons. More importantly, consumers should assume any size handheld battery-powered laser they do not directly control has the potential to blind or permanently affect eyesight.
One way to determine if such a laser has been manufactured to regulatory power and hazard class limits is to find labeling. The labeling that comes with the laser (and online labeling) must display the power, hazard class, and wavelength. The wavelength is a number that describes the color of the beam.
The label must display the laser power. It must be 5 milliWatts or less. The label must display the hazard class. It must be Class I, Class IIa, Class II, Class IIIa or Class 1, Class 2 or Class 3R."
Survival Lasers used to sell diodes, complete kits, and fully assembled lasers in the USA. THe FDA put and end to it. All you Survival Lasers can do in USA now is sell everything but the diodes so he is not seen as selling complete lasers or kits for same.
As the owner of Survival Lasers said in post #13 here: http://laserpointerforums.com/f44/question-about-survival-lasers-88504.html
"you wouldn't think it was so stupid if you received a series of letters from the FDA (that's the U.S. Food and Drug Administration, the federal agency charged by Congress with the regulation of "radiation producing" products like lasers, among other things) threatening to fine you and/or shut you down if you didn't comply with their policy of selective interpretation and enforcement of their regulations.
Do you seriously think I would of my own free will turn down sales from my fellow citizens??
The SL USA site was specifically constructed after a number of exchanges with the FDA about what they would and would not consider violations of their regulations. We also racked up significant legal fees during this process.
The reason others here are still selling is that they are not yet on the FDA's radar, or are not selling a combination of parts that could be construed as "lasers" or "laser products" as the FDA defines them. If they continue long enough, or become visible enough, I'm sure they will be contacted as well.
If you are unhappy with this policy, I would recommend you contact the FDA and express your concern and opinion about their regulations and enforcement practices. We appreciate all the support we can get and we would love to be able to resume shipping all of our products to US customers. "
As a result of FDA laws, rules, and regulations all you will find is one group of people selling hosts and not diodes and another group selling just diode, drivers, other parts not including hosts.
"FDA regulates all laser products, even handheld, battery-powered lasers that are available for purchase FROM manufacturers, importers, assemblers, dealers or distributors in the United States and its territories. This includes lasers manufactured or obtained on a continuing basis for the purpose of sale or resale.
FDA requires that manufacturers of these lasers limit the power of the laser light to 5 milliWatts (often abbreviated as "mW") or less. The labeling or packaging must allow the purchaser to know the power of the laser, its hazard class, and its wavelength before the laser is purchased. Even online advertisements must display this information for the purchaser.
Even the smallest handheld, battery-powered lasers are capable of emitting laser light at hazardous powers. Larger models, the size of a small flashlight, can burn skin and pop balloons. More importantly, consumers should assume any size handheld battery-powered laser they do not directly control has the potential to blind or permanently affect eyesight.
One way to determine if such a laser has been manufactured to regulatory power and hazard class limits is to find labeling. The labeling that comes with the laser (and online labeling) must display the power, hazard class, and wavelength. The wavelength is a number that describes the color of the beam.
The label must display the laser power. It must be 5 milliWatts or less. The label must display the hazard class. It must be Class I, Class IIa, Class II, Class IIIa or Class 1, Class 2 or Class 3R."
Survival Lasers used to sell diodes, complete kits, and fully assembled lasers in the USA. THe FDA put and end to it. All you Survival Lasers can do in USA now is sell everything but the diodes so he is not seen as selling complete lasers or kits for same.
As the owner of Survival Lasers said in post #13 here: http://laserpointerforums.com/f44/question-about-survival-lasers-88504.html
"you wouldn't think it was so stupid if you received a series of letters from the FDA (that's the U.S. Food and Drug Administration, the federal agency charged by Congress with the regulation of "radiation producing" products like lasers, among other things) threatening to fine you and/or shut you down if you didn't comply with their policy of selective interpretation and enforcement of their regulations.
Do you seriously think I would of my own free will turn down sales from my fellow citizens??
The SL USA site was specifically constructed after a number of exchanges with the FDA about what they would and would not consider violations of their regulations. We also racked up significant legal fees during this process.
The reason others here are still selling is that they are not yet on the FDA's radar, or are not selling a combination of parts that could be construed as "lasers" or "laser products" as the FDA defines them. If they continue long enough, or become visible enough, I'm sure they will be contacted as well.
If you are unhappy with this policy, I would recommend you contact the FDA and express your concern and opinion about their regulations and enforcement practices. We appreciate all the support we can get and we would love to be able to resume shipping all of our products to US customers. "
As a result of FDA laws, rules, and regulations all you will find is one group of people selling hosts and not diodes and another group selling just diode, drivers, other parts not including hosts.
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