Whose laser pointers comply with FDA

[lazerphase]

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

 

[Pi R Squared]

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.

Alan

 

[Laik]

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...

 

[Livinloud]

Ive got a laserbtb HL coming my way....closest thing to full FDA approval ill ever own.....maybe

 

[Bionic-Badger]

Your laser pointer must be < 5mW, otherwise it is considered a laser module.

 

[hwang21]

Or handheld laser^

 

[HitShane]

I thought it was "Portable".

 

[Garoq]

No handheld high-power (>5mW) laser is "FDA compliant".

 

[Bionic-Badger]

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.

 

[Garoq]

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.

 

[Justin]

Having maintained a relationship with various contacts at the FDA/CDRH for many years now I can assure you that this is not true.

 

[Livinloud]

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?

 

[Garoq]

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.

 

[Justin]

"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.

 

[Garoq]

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.