I was just looking at the PL forum and found this post by a member named "buffo"
in a thread that was being quite negative about the Wicked Laser claim relating
to CDRH compliance...
Well, after some more research, it turns out that I was grossly mistaken.
Sorry guys, but Wicked Lasers is correct: The CDRH rules *HAVE* changed, and most of us here didn't even know it. We all were looking at the Code of Federal Regulations, but we didn't consider that the CDRH also sends out Laser Notice letters from time to time which serve as "interpretation of the federal standard", at least until Congress gets around to approving those changes into the federal code.
So the gem that we all missed was Laser Notice # 50, which offers manufacturers *and* importers another way to certify their laser products. This "other way" is to certify the product under the International IEC standard for laser products (IEC 60825-1 and IEC 60601-2-22). If you meet the IEC standard, then you don't have to meet the 21CFR1040.10 standards for a number of items. And these items are precisely the items that we're complaining about. (Like having a mechanical shutter on a solid state laser, or requiring an emission delay circuit.)
Here is an except from Laser Notice # 50:
Quote:
CDRH will not object to conformance with the
comparable sections of IEC 60825-1, as amended by Amendment 2 of January 2001 in lieu of conformance with the following sections of 21 CFR §1040:
And then there are a bunch of sub-sections listed. Look at the document yourself for the details - there are far too many to list here.
Note that not all of 21CFR1040 has been superseded! There are still some US requirements that go beyond the IEC standard. (Mostly related to labeling, variances, and quality control items for laser manufacturers - again, read the notice to get the details.) But the important thing is that the IEC standard does have some relaxed rules that will be *BIG* changes for US manufacturers (or importers).
What does this all mean? It means that I didn't understand the US rules as well as I thought I did. It means I was wrong. As far as I can tell, Wicked Lasers' new line of hand held lasers *are* compliant with these new regulations. I do want to do some more research on the matter, however.
Adam
It seems there is a variance and as Steve said... WL Lasers seem to be legal...
Here's a second post by "buffo" with more info on the efforts WL has done to get
compliance for their Lasers..
Yeah, me too pal... I've got some crow to eat it seems!
I've also been able to verify that Wicked Lasers has been working with Casey Stack at Laser Compliance Inc. for over a year to bring their lasers into compliance with the IEC rules. This isn't just some marketing gimmick for them - they've invested a good deal of money into this project.
For those who may not know, Casey Stack is one of the industry heavyweights when it comes to Laser Safety here in the US. He's been in the industry since the late 1980's, and he's worked for all sorts of companies. He was very active in ILDA back in the early 90's when all the standards we use today were being drafted. Today he helps laser companies navigate the legal minefields here in the US.
I've spoken with a lot of people about this topic, and you would be surprised at how many people were under the same mistaken impression we were - namely that these lasers absolutely could not be legally sold in the US. But it turns out that Wicked Lasers is right and we were all wrong. (oops!)
Adam
:gj: buffo (Adam)...
I'm sure that Steve and Wicked Lasers will graciously accept this apology...
Jerry