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Old 05-15-2015, 01:21 AM #1
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Default New FDA "pointers" regulation page published today 05/14/2015

"Does FDA regulate these new powerful laser "pointers" and are they hazardous?
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.

REMEMBER:

Do not purchase a handheld, battery-powered laser labeled with hazard Class IIIb, Class IV, Class 1M, Class 2M, Class 3B or Class 4 unless the manufacturer has an approval from FDA (called a "variance") to allow the purchase. Lasers approved for purchase in these classes often have very specific uses and may be sold under certain conditions known to the manufacturer. Sales without a variance, or sales that violate the conditions of the variance, ARE ILLEGAL.
No laser, no matter what class or power, should be pointed at the eyes or reflected into the eyes from a mirror surface. No laser, no matter what class or power, is safe to shine at the operator of aircraft, watercraft, or vehicles.
Laser light remains powerful and bright many miles or kilometers from the laser.
Unlabeled lasers or lasers you do not control should be assumed dangerous, too powerful for most intended consumer uses, and could damage your eyesight from a momentary direct or indirect exposure to the beam.
Handheld, battery-powered lasers have power and class limits for a reason; to prevent eye and skin damage. Laser light can damage eyesight in less time than you can blink or look away. Do not assume lasers offered for sale as "approved" or "safe" are not hazardous."

From: Does FDA regulate these new powerful laser "pointers" and are they hazardous?



Last edited by Encap; 05-15-2015 at 01:25 AM.
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Old 05-15-2015, 02:00 AM #2
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Default Re: New FDA "pointers" regulation page published today 05/14/2015

So honestly how does this affect us users in the USA? It sounded like they were either limiting every laser to 5mw or just restating the laws! Sry my axolotl tank just crashed and they all died. So I'm a few beers deep on the situation
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Old 05-15-2015, 03:33 AM #3
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Default Re: New FDA "pointers" regulation page published today 05/14/2015

Quote:
Originally Posted by Tha Greenlander View Post
Thank you for posting new FDA rules concerning lasers Encap!

Nevertheless, the FDA is making a mistake by telling people that labeling on a laser determines if it is safe or not. A label is NEVER a safe way to determine what the laser could be outputting! I know some may find this silly, but this could lead people to believe those "<5mW" pointers from China are safe, in reality they have more then enough power to cause injury or damage.

-Alex
??? lol Did you read the whole thing? I understand you point but is a different one from the FDA's point.
Is not what they are talking about in that section. It is not speaking about Dr. Evils illegal 3W laser labeled <5mW nor otherwise illegal, misrepresented, incorrectly labeled lasers of whatever manufacture that do not comply with FDA rules and regulations.

I think they did a good job of saying what they wanted to say.

FDA are the regulatory authority. They are writing about products that comply with all FDA rules and regulations "pointers". What can be and is legal, not what is illegal. They are very clearly talking about "legal" according to FDA regulations lasers in that section and later giving some cautionary notes.

They say "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."

and given that is true in that light they then say:

"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."

They are right . It is as good a way and as good a guidance as it is meant to be or might be about lasers that comply with the FDA Rules and Regulations. Otherwise there is no reason for rules and regulations nor for labels of any kind at all. Not what FDA , as the regulator of lasers in USA, is about.

They even go on to say under REMEMBER:
"1.No laser, no matter what class or power, should be pointed at the eyes or reflected into the eyes from a mirror surface. No laser, no matter what class or power, is safe to shine at the operator of aircraft, watercraft, or vehicles.

2. Laser light remains powerful and bright many miles or kilometers from the laser.

3. Unlabeled lasers or lasers you do not control should be assumed dangerous, too powerful for most intended consumer uses, and could damage your eyesight from a momentary direct or indirect exposure to the beam.

4.Handheld, battery-powered lasers have power and class limits for a reason; to prevent eye and skin damage. Laser light can damage eyesight in less time than you can blink or look away. Do not assume lasers offered for sale as "approved" or "safe" are not hazardous."
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Old 05-15-2015, 05:15 AM #4
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Default Re: New FDA "pointers" regulation page published today 05/14/2015

Hey Encap, thanks for posting this, and also for linking to the FDA page at the end. I'm glad to see that they are still focused on the manufacture and sale end of things, rather than crossing that bridge into ownership and possession territory. I believe THAT would be serious overreach.

Do you know if this release represents any major change in regulatory policy? It doesn't appear to include any new CDRH findings or recommendations.

On a separate note: I'm very sorry to hear about what happened to your axolotls, 10fenny. Seriously, that really sucks, and I wish I could do more than offer mere condolences. FWIW, I just cracked open a beer over here ...............just so you're not drinkin' alone.
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Old 05-15-2015, 05:54 AM #5
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Default Re: New FDA "pointers" regulation page published today 05/14/2015

I mean, all these regulations are good, sure. All the safe practices are good. The problem is, no common man knows or understands the laws or the safe practices. The eBay lasers are all marked as <1mW or <5mW when they can produce >100mW. The people who buy them treat them as cheap toys they can mess with, without safety goggles or an understanding of lasers.

As far as I can tell, the FDA has managed to restrict the responsible laser users, while largely missing the large majority of laser-related incidents, the idiots who shine their cheap lasers around without any clue of what they're doing. And making stricter regulations won't change that, especially when all the eBay lasers make it through those regulations anyway
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