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FrozenGate by Avery

FDA compliance?






jaybob said:
Does this laser comply with FDA regulations?
50mw 532nm Handheld Adjust Focusing Green Laser Pointer with Double-protection device SD-300(1*18650) - DinoDirect.com

Knowledgable answers only preferably, thanks for your help!
Click to expand...
The way I understand it.....

It is only FDA approved if the FDA approves it.
The only one that would know is the FDA and
DD with the proof of a valid accession number
from the FDA...

Getting a Radiation Emitting Product to Market

Not sure if that is knowledgeable enough...:undecided:


Jerry
 
Last edited:
probably not
1. the price
2. it doesnt look like it has those "smart switch" featured that the FDA require
 
jaybob? jayrob?
that threw me off.
i would love to get a laser approved by the FDA but the headache is not worth it for a hobby.
 
From what I understand, even the Arctic, which has a "smart switch" is not FDA approved....:thinking:
 
thats because the power on "lag" time is less than 5 secs...
that way the arctic "appears" to be FDA approved, but actually isnt
 
I thought the smart switch was required only for class IV lasers or is it for IIIb as well?
 
No portable class IV laser is FDA approved, period. Furthermore, portables and pointers will soon if not already fall under 21 CFR 1040.11(b) surveying, leveling, and alignment laser products with maximum of class IIIa output per information I received from the CDRH.
 
Thanks for the info. Nice to hear it from someone who works in the industry and isn't just speculating out their rear orifice like I was.
 
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