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Old 06-14-2013, 02:57 AM #17
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Default Re: Whose laser pointers comply with FDA

Im beginning to do a lot more builds because of this FDA thing but its not like it really stopped me from buying lasers over 5mW


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Old 06-14-2013, 03:35 AM #18
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Default Re: Whose laser pointers comply with FDA

Don't forget that its not just the FDA but there are also some FAA and OSHA regulations that can apply depending on how and where the laser is used. For example to do an outdoor laser light show or even to use lasers for surveying in the US you need a variance from the FAA. You also can't shine it in the sky if your within 10 miles of an airport or even if your only in the flight path but more than 10 miles out. If a laser is used in a workplace there are requirements for warning signs and certified safety glasses.

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Old 06-14-2013, 04:49 AM #19
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Default Re: Whose laser pointers comply with FDA

In Australia, i don't think a cop is going to say "whoa mate, that thing is pretty sweet," i think it will be more like "give me that laser and put your hands behind your head, you are being charged with... ugh... well im gonna charge you for something. It would really help if you told me were your drugs were as well."

Yeah, only in...
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Old 06-14-2013, 10:52 PM #20
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Default Re: Whose laser pointers comply with FDA

Ive got a laserbtb HL coming my way....closest thing to full FDA approval ill ever own.....maybe
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Old 06-15-2013, 12:01 AM #21
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Default Re: Whose laser pointers comply with FDA

Your laser pointer must be < 5mW, otherwise it is considered a laser module.
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Old 06-16-2013, 01:21 AM #22
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Default Re: Whose laser pointers comply with FDA

Or handheld laser^
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Old 06-16-2013, 05:26 AM #23
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Default Re: Whose laser pointers comply with FDA

I thought it was "Portable".
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Old 06-17-2013, 01:04 AM #24
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Default Re: Whose laser pointers comply with FDA

No handheld high-power (>5mW) laser is "FDA compliant".
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Old 06-17-2013, 02:07 PM #25
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Default Re: Whose laser pointers comply with FDA

They can be hand-held, as it would be hard to prevent smaller lasers from being hand-held (e.g. a CNI PGL-III), but they must be certified according to FDA 21 CFR 1040.10 and 1040.11 including the 5-point safety features (3-second delay at startup, remote-control interlock, key control interlock, shutter, emission operational indicator), indicator stickers, and other things. The certification is key, because just having those 5-safety features doesn't mean it can be sold. This assumes that there is direct access to the laser, not that it is enclosed in something where the above safety features are not needed; the enclosure and operational mechanisms would need to be certified.

Laser pointers, on the other hand, must be eyesafe (Class 3a/3r), and can have momentary switches.
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Old 06-18-2013, 11:55 AM #26
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Default Re: Whose laser pointers comply with FDA

Quote:
Originally Posted by Bionic-Badger View Post
They can be hand-held, as it would be hard to prevent smaller lasers from being hand-held (e.g. a CNI PGL-III), but they must be certified according to FDA 21 CFR 1040.10 and 1040.11 including the 5-point safety features (3-second delay at startup, remote-control interlock, key control interlock, shutter, emission operational indicator), indicator stickers, and other things. The certification is key, because just having those 5-safety features doesn't mean it can be sold. This assumes that there is direct access to the laser, not that it is enclosed in something where the above safety features are not needed; the enclosure and operational mechanisms would need to be certified.

Laser pointers, on the other hand, must be eyesafe (Class 3a/3r), and can have momentary switches.
Unfortunately the FDA considers all hand-held portable lasers "SLA" (surveying, leveling and alignment) and are limited to 5mW output regardless of safety features and certifications.
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Old 06-19-2013, 05:33 PM #27
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Default Re: Whose laser pointers comply with FDA

Having maintained a relationship with various contacts at the FDA/CDRH for many years now I can assure you that this is not true.
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Old 06-19-2013, 08:28 PM #28
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Default Re: Whose laser pointers comply with FDA

Quote:
Originally Posted by Justin View Post
Having maintained a relationship with various contacts at the FDA/CDRH for many years now I can assure you that this is not true.
To what statement?
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Old 06-19-2013, 08:37 PM #29
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Default Re: Whose laser pointers comply with FDA

Quote:
Originally Posted by Justin View Post
Having maintained a relationship with various contacts at the FDA/CDRH for many years now I can assure you that this is not true.
Yes, what part is not true? I am telling you what they have told us and our attorneys in writing. This is their current position.
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Old 06-21-2013, 01:33 PM #30
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Default Re: Whose laser pointers comply with FDA

"the FDA considers all hand-held portable lasers "SLA" (surveying, leveling and alignment) and are limited to 5mW output regardless of safety features and certifications. "

This is not what I have heard from my contacts at the FDA/CDRH. They are a large organization, so perhaps there is some inconsistency in how they interpret their own regulations, or perhaps they treat you differently because you are within the USA. At any rate, we have been granted accession numbers for plenty of >5 mW handheld lasers and when they are inspected by Customs or the FDA they always clear without a problem.
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Old 06-21-2013, 04:46 PM #31
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Default Re: Whose laser pointers comply with FDA

I'm sure anything's possible. Perhaps they have changed their handheld laser policy since you were last granted an accession number. Or, maybe they just don't like conservatives.
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Survival Laser, Inc., 2113 W 850 N, Cedar City, UT 84721

Hosts AW Batteries Chargers Diode Drivers Laser Safety Goggles Lenses Accessories

U.S. customers store link>> http://www.survivallaserusa.com
International customers store link>> http://www.survivallaser.com

LPF member 10% everyday discount code = LPF445
Free shipping on US orders over $100 net
Free shipping on international orders over $200 net
Click here for great laser deals for our international customers

PLEASE READ THIS BEFORE BUILDING OR USING A HIGH POWER LASER!

7 Watt S4X Host/NUBM44 Diode/SXD Tutorial
C6 Laser Assembly Tutorial
How to Install a Blank Battery Contact Board Into a Drilled Pill
How to Solder a DTR Diode Module to a Survival Laser Driver & Pill Assembly
Installing and Testing the SL-SD-1/DX 26110 Driver in a C6 Pill
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