Legal Varianced Chinese Laser

[JD3]

Regarding the Able Laser AB-IV and AB-III models I spoke with the CDRH and they have informed me that the lasers are legal and compliant. See below

"Hello Mr. Dickson,

I apologize for the delay in responding to your question. I was not able to do so because of the shutdown.

The firm Quangzhou Able Laser, aka Guangzhou Able Entertainment Lighting, does have the variance you identified. It was issued in 2010 and has been renewed each year since. So it is currently in effect.

The variance explicitly mentions their model family AB-IV, but it permits them to add additional Class IIIb or IV models to their list of models. The AB-III model family is such an addition and so is certifiable under the variance. There are restrictions on the effects the models may produce, specifically including no audience scanning or exposures.

The projector should have a certification statement on it, either in a separate label or combined with the firm’s identification label.

I hope this answers your concerns. If you have any more questions, feel free to ask me.

Sincerely yours,

Dale Smith, CSO
Magnetic Resonance and Electronic Products Branch
Division of Radiological Health | OIR/CDRH/FDA
"

[JD3]

Specs for said laser

2.5W
R:500mw/637nm, G:1w/532nm, B:1w/445nm
CNI diodes, 10khz analog modulation
R:＜1.0mrad divergence, 3mm diameter
G:＜1.0mrad divergence, 3mm diameter
B:＜1.2mrad divergence, 3mm diameter
DT40 pro scanners, scan speed is 40kpps, 60 scan angle
RJ45 network & ILDA DB25 in/out ports
Housing is sealed, dust-proof
N.W:10kgs, Dimension:309*226*191mm
Warranty: 12 months for diodes, 24 months for scanners, 100% money back if dissatisfaction within 7 days.

Attachment 40594
Attachment 40595
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[Mlenox]

Price?

Is a personal Variance still needed?

[Displaser]

Is a personal Variance still needed?

Yep. You will need a variance for you, such as a "mobile" variance, along with the required variance for the projector. Shouldn't be a problem,, as there are many on the forum that have them.

Greg

[JD3]

Yep. You will need a variance for you, such as a "mobile" variance, along with the required variance for the projector. Shouldn't be a problem,, as there are many on the forum that have them.

Greg

^what he said. I spent the past two months making sure this was going to be possible.

I don't like to waste money lol

[JD3]

Attachment 40599
Attachment 40600

For Greg,
The front pic is crappy quality

[gottaluvlasers]

Not to piss on your parade buddy but like i have told you and many other people from this forum, a piece of paper means ZILCH!!!! I give ABLE MAD Kudos for DOING the paperwork, but just from the pictures alone I can tell that the unit is not compliant.

1) No certification statement
2) Key can be removed in "ON" position
3) No beam masking on aperture (AKA shutter / or beam attenuation to satisfy the regs)
4) Just from my own first hand experience with them at LDI last year (I was the LSO for the event) the systems *DID NOT* satisfy class 4 Laser requirements.

There was no- "ON" delay. There was no power off manual reset. There was no ILDA cord disconnect, fail safe. IN addition to the above mentioned non compliant issues.

A product report can be submitted for a toaster oven with a wicked lasers 20 Watt super duper arctic light saber. The report can be approved and a variance can be issued. HOWEVER- it quite obviously is NOT a "legal" laser system.

Laser certification relies on HONEST, SAFE and PROFESSIONAL laser system building and reporting. On top of EVERYTHING else non-compliant with the systems mentioned here- i am curious as to who their "Keeper of records and Quality control" is in the USA (Required as per 21 CFR and reported as such).

No offense and I dont want to sound like an asshole, but when are you guys going to realize that when you can pay $2500 for a 3,4 or 5 Watt Laser from China *SOMETHING,* *SOMEWHERE,* *SOMEHOW" is not being done properly. Either poor build quality, improper or outright dishonest power claims or a whole combination of the above.

Come on guys and gals- Start using your noodles and start using common sense. Im not preaching to not buy chinese. Obviously that isnt going to happen. But dont fool yourselves into thinking you are getting something you're not.

-Marc

[JD3]

I forwarded the pictures to the CDRH as well

[gottaluvlasers]

JD3- (sorry, I forgot your name)

lol, I don't get into pissing matches. I think discussions like this provide excellent information for MANY people. Myself included. I *DO NOT* claim (nor have I ever) to be the end all, be all of Laser compliancy. I don't even think the CDRH can claim that title!

However, what I do try to do is provide as much "first hand knowledge" and/or experience to guide and/or educate potential buyers. I understand you are not going to buy one of my systems. I completely understand that not everyone has a $7000+ budget for Laser systems. But I get my sexy panties in a bunch when I see people being "steered wrong" or outright lied to. I *AM NOT* saying ABLE lied. In fact, of all the Chinese manufacturers ABLE and CR Tech happen to be pretty impressive to me. I am just trying to make you and others aware that, AS FAR AS MY EXPERIENCE and *MY* knowledge of Laser regulations (which I think is pretty extensive), These systems are *NOT* compliant according to 21 CFR 1040.10. An I'll bet you my left nut that they are not adhering to their submitted product report.

I applaud you for doing your homework, and in all honesty- I think ABLE is a good choice for your first Laser. I just am trying to convey that you need to be aware of possible issues with compliancy. If I am wrong, GREAT! I hope I am.

-Marc
-

[JD3]

JD3- (sorry, I forgot your name)

lol, I don't get into pissing matches. I think discussions like this provide excellent information for MANY people. Myself included. I *DO NOT* claim (nor have I ever) to be the end all, be all of Laser compliancy. I don't even think the CDRH can claim that title!

However, what I do try to do is provide as much "first hand knowledge" and/or experience to guide and/or educate potential buyers. I understand you are not going to buy one of my systems. I completely understand that not everyone has a $7000+ budget for Laser systems. But I get my sexy panties in a bunch when I see people being "steered wrong" or outright lied to. I *AM NOT* saying ABLE lied. In fact, of all the Chinese manufacturers ABLE and CR Tech happen to be pretty impressive to me. I am just trying to make you and others aware that, AS FAR AS MY EXPERIENCE and *MY* knowledge of Laser regulations (which I think is pretty extensive), These systems are *NOT* compliant according to 21 CFR 1040.10. An I'll bet you my left nut that they are not adhering to their submitted product report.

I applaud you for doing your homework, and in all honesty- I think ABLE is a good choice for your first Laser. I just am trying to convey that you need to be aware of possible issues with compliancy. If I am wrong, GREAT! I hope I am.

-Marc
-

Its John

I agree it does provide good information. Ive done a TON of digging about these laser systems.
I technically CAN afford your lasers... BUT (this is where i know it will make most of the Compliant US guys mad) why pay 7000 when i can pay 4000 and achieve damn near the same effect. I understand when it comes to warranty and shipping and language barrier etc etc etc. that buying more local would make sense.

I have 3 lasertainment lasers right now, 1 of them only came with aperture sticker the other 2 came with all the stickers needed. None of them have a "case open" interlock, which some claim is required to be compliant. They also do not have a physical beam block or shutter.
At this point we go back to the CDRH being able to make grey with white paper and black ink lol.

I forwarded the pictures to the CDRH and i will also ask them what is the Minimum required saftey features that will make this laser compliant. It seems some manufactures pick and choose from this "list" of features to ensure compliance.

Once i get a reply, ill ask Able if this laser has all of these features. If they agree that it does, i will buy it, open it, and check. If it is indeed not compliant i will take advantage of their 7 day money back guarantee (if they hold true to that)

I am new to this game but i read, and read, and read, and read, and read, sleep, then read more. So I believe i have a fairly firm grasp on all of this, but have this disadvantage of never laying eyes on one of these as you have.