# FDA CDRH post from Wickedlasers Forum



## comozo (Oct 9, 2004)

I'll preface this by saying I really don't care what the above government agencies say about laser pointers. I am inclined to buy one of greater than 5mw output.The point I was making is that certain companies,I won't name names this time, are violating the rules and regulations set forth by the FDA and CDRH but say they are not.I'd hate to see them be forced out of business or worst. It may behoove them to change their product line but still sell portable laser products. If not the only options are the more expensive laser modules.
There is a thread which can be found at Google's>Groups>alt.lasers which is called "A Phone Call to the CDRH". While it does not mentions pointers it is interesting none the less. I don't know who Dr. Bullough is ,but the names and numbers he sites are very much real

"Dr. John D. Bullough
I've reviewed this site and yes the products that are sold as complete products (not to be integrated into a compliant and certified product) are clearly in violation of FDA regulations. 

Feel free to contact the FDA at any time to discuss your concerns! 

1-240-276-0120 

The following people will be very familiar with the regulations and interesting in discussing this site as well: 

Jerry Dennis, extension 135 
Frank Mackson, extension 145 
Dale Smith, extension 147"


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## gregw (Oct 9, 2004)

Here is the thread.

Good information..


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## shadow_of_chaos (Oct 10, 2004)

too bad, i dont see any harm in owning something illegal.. if you are not doing anything illegal with it, like using it as it should.. point to stars or just mess around indoors.


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## comozo (Oct 10, 2004)

You miss the point. The violation is not in the owning of it, but in the selling of it. You can modify your laser pointer or build one into a multi-megawatt death ray, that is not a violation either. I do love playing the Devils Advocate.


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## 2dim (Oct 10, 2004)

Multi-megawatt death ray? Please post specs and PM instructions. Any BEAMSHOTS?


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## comozo (Oct 10, 2004)

I was merely making a point by exaggeration.


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## 2dim (Oct 10, 2004)

Just funnin', bro'...


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## gorn (Oct 10, 2004)

Now that someone has let this genie out of it's bottle to the FDA I wonder how long it will be before Abeland and Z-Bolt get a visit.

I hope this wasn't started by one of the people selling the laser to shut down competition. It just may bite them, and those of us who have the lasers in the butt.


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## shadow_of_chaos (Oct 11, 2004)

True, not very nice if they want them shut down.. i'm grateful their even selling high mw lasers.


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## sharkeeper (Oct 11, 2004)

They won't shut them down.

They will ask them nicely (the first time) to stop selling non compliant products.

Just ask Jure Slabic of extremelasers.com what happened. He only (now) sells legal aka 5mW max pointers.

This is an open-closed case folks.

If you want a hopped up pointer, go ahead and make it yourself. Nothing can stop you from doing that.

I noticed the post was deleted on that forum. It still is cached on search engines, however.

Cheers!


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## comozo (Oct 12, 2004)

A way to keep selling high powered pointers. First the seller determines which pointers can and to what output level. Second sell them at 4.99mw along with instructions and a list of tools needed on how to increase the output to the desired level. This way no laws have been broken and the seller stays in business. Another possibility may be to sell them without a collimating lens, without a lens the pointer is relatively useless.


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## OddOne (Oct 12, 2004)

Hehehe, for my laser (way large power Nd:glass monster that it is) the safety interlocks include passive-IR sensors that break the trigger circuit connections if a warm-blooded anything is even in the room with the laser. Then again, you don't really wanna share a room with a laser capable of putting a clean 1" dia. hole in a manhole cover. /ubbthreads/images/graemlins/eek.gif 

The CDRH gets really pissy about class-4 lasers, BTW...

oO


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## John_D_Bullough (Dec 17, 2004)

Interesting, but in the Google thread that seems to be attributed to Dr. John D. Bullough (who happens to be me) the source of the info is Ray Condo. I came across this thread accidentally - I don't know nothin' about lasers. /ubbthreads/images/graemlins/smile.gif


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## Spec (Dec 17, 2004)

[ QUOTE ]
*sharkeeper said:*
They won't shut them down.

They will ask them nicely (the first time) to stop selling non compliant products.

Just ask Jure Slabic of extremelasers.com what happened. He only (now) sells legal aka 5mW max pointers.



[/ QUOTE ]

I contacted Jure quite a while ago and he responded with

"Dear Robert, we at one period of time offered pictures of modified green
laser pointers. However, at no time did we sell these products. In fact,
the
caption clearly noted the dangers of these pointers and the CDRH guidelines
to
handling them. Once people (without experience) tried replicating the
pictures
we had, we decided to take them down. Modified green laser pointers are
completely unreliable, unstable, and hazardous. They are comparable to
putting a
super charger on a 74' Pacer."


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## sharkeeper (Dec 17, 2004)

Well I know for a fact that he sold them (2001) as I was offered a 35 mW one for $650 back then. Also, the 57mW picture was on his site with a caption reading something of the like of "our capabilities" and this prompted FDA actions.

Anyways, it's interesting to see this post bumped by someone that claims to be the doc yet knows nothing about lasers! WTF?

Perhaps a breach at A51 has unleashed some gremlins into the realm of CPF. /ubbthreads/images/graemlins/grin.gif

Cheers!


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## Spec (Dec 17, 2004)

Before I respond to your thread I need you to be extremely specific as to whom you are making reference to and to what extent.

A quick glance makes your post read like a personal attack based on faulty and uninformed information.

To clarify:

THAT is the EXACT email I recieved from him back in October, whether it is true or purely CYA is up for discussion.

You clarify the rest.


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## sharkeeper (Dec 17, 2004)

http://web.archive.org/web/20020605130454/extremelasers.com/Modify2.htm


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## Spec (Dec 17, 2004)

Funny, I have also checked cache files:

http://web.archive.org/web/20020523205420/http://extremelasers.com/

Read the bottom of that page.

I was not interested in lasers or pointers back in 2001. I have no idea whether or not you were given an offer for one. If you were, more power to you.

What still stands is that the personal attack was completely uncalled for and childish.

I will ask one more time: Clarify your post with specific details so it can be dealt with in a mature fashion, or issue a formal apology.

Never the less, Im quite interested in hearing your reasoning behind the comment.


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## DaFiend (Dec 17, 2004)

That photo, the one that says "property of Kevin Nardelle", he's the guy who owns that site i posted the other day, the DPSS Mod page.


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## sharkeeper (Dec 17, 2004)

Sorry but your definition of personal attack must be different than mine...

I keep all emails and I'm sure I could find any correspondence with said individuals but what's the point?

Fact 1: This person was selling lasers > 10 mW on ebay in 2001 labeled as "forensic pointers".

Fact 2: This person did have said lasers on web site with a link to email request and this is how I got in touch with them.

Fact 3: They were snitched on by another laserist concerned with safety and I will not disclose that person's name.

Fact 4: The website was amended shortly thereafter with a quote from Frank Mackson of the Center for Devices and Radiological Health.

This was in late 2001 early 2002.

That is where I based my statement on which you take as a personal attack which is absurd. I rest my case.

Cheers!


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## Spec (Dec 18, 2004)

[ QUOTE ]
*sharkeeper said:*
Anyways, it's interesting to see this post bumped by someone that claims to be the doc yet knows nothing about lasers! WTF?

Perhaps a breach at A51 has unleashed some gremlins into the realm of CPF. /ubbthreads/images/graemlins/grin.gif

Cheers! 

[/ QUOTE ]

That quote is what I am questioning the nature of as a personal attack. I see Re:Spec as the direct responce header, I can only assume you meant that comment specifically for me.

If that is not the case, and you did not mean that quote for me, then I made a mistake by reading the reply header.

However, If it was given as a direct responce to me, then by design, it is a personal attack.

I apologise for anyone having to wade through this garbage, I attempted to do this over email but the recipient email account bounced it back.


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## sharkeeper (Dec 18, 2004)

No I was referring to this John D. Bullough person that says they don't know anything about lasers. 

Of course if you take what they said in context, a double negative means they do. /ubbthreads/images/graemlins/wink.gif

I don't know if you tried emailing me but my address most certainly does work.

Cheers!


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## Spec (Dec 18, 2004)

I apologise for causing any confusion and in the future I will avoid looking at the reply header information. /ubbthreads/images/graemlins/wink.gif

Apon closer inspection of the returned email I recieved It looks like my account bounced it. It has been arguing with me for quite a while now due to all the new anti-spam policies being issued by my host.

Once again, I am sorry for the uproar, please forgive me.


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## sharkeeper (Dec 18, 2004)

No problem!

Carry on!


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## Shiftlock (Dec 19, 2004)

Just an FYI, the extremelasers.com domain name was registered on 30-Mar-2002, so any reference to what it contained in 2001 is not possible.

Whois Results from TUCOWS INC.:
Domain name: EXTREMELASERS.COM
Registrar of Record: TUCOWS, INC.
Record last updated on 23-Sep-2004.
Record expires on 30-Mar-2006.
Record created on 30-Mar-2002.
Domain status: ACTIVE


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## Raccoon (Dec 19, 2004)

Also funny how the archive.org _proof_ clearly contains "2002" in its url.

http://web.archive.org/web/*/http://www.extremelasers.com

But, besides the point, we all know that plenty of "illegal" lasers have been sold by all parties involved. Jure was particularly careful about who he sold them to.

I'm more surprised by how long it took eBay to crack down on it.


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## sharkeeper (Dec 19, 2004)

[ QUOTE ]

Just an FYI, the extremelasers.com domain name was registered on 30-Mar-2002, so any reference to what it contained in 2001 is not possible.

[/ QUOTE ]

His original site was hosted on tradewins, a free site like geocities/yahoo, etc.

EDIT: Ok his site was hosted on crosswinds not tradwins. /ubbthreads/images/graemlins/blush.gif

Here is the original URL:

http://greenlaser.crosswinds.net/greenlaser2.htm

Of course the page hasn't been there since he registered extremelasers.com. This is back when Jure was getting started.

Cheers!


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