Legal Varianced Chinese Laser

[JD3]

* sorry i deleted my post after reading it again, didnt wana be an asshole*

[JD3]

http://www.fda.gov/downloads/Medical.../UCM095304.pdf
^ compliance list
Page 11 discusses need (and exemption) of beam attenuators.
It seems that you can can request to "opt out" of a lot of features listed.

[daction]

sorry if I am off topic. Where would I get a safety shutter from? I have wired in the connection for it (stanwax ilda board).
Do they need a driver or do they run off the ilda board?
Regards
dan

[LaserWolf]

All good info. Thanks guys.

[JD3]

"I’m not sure I can confirm non-compliance, but what I don’t see are all of the required labels on the product. I would expect to see the certification and identification label(s) with the other labeling on the left of the back surface. In addition, there would be an aperture label(s), a warning logotype or IEC laser symbol and information labels, a non-interlocked or defeatably interlocked protective housing label, etc. None of these labels are seen in the picture.

The controls and connectors on the back are not clearly enough labeled for my eyes, though I do see the ON/OFF switch and the ILDA connectors.

So, if there are no labels, the projector definitely is not compliant. From the picture I can not tell whether there are engineering performance features or whether they work as required.

Note that the CE mark is NOT equivalent to a certification of compliance with our laser standard.

Sorry for the bad news.

Sincerely yours,

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

[JD3]

Able Laser informed me that they proved the stickers "loose leaf" in the box so that you can affix them where your country's regulations state.

Awaiting more detailed pictures of the unit from Able

[Bradfo69]

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.

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

Marc, I get it. Really I do. But, playing devils advocate as I like to do from time to time forces me to ask a couple questions about this reply.

1) I'd like to know how you can tell the key can be removed in the on position from a picture.

2) In your examination of the boxes at LDI, you said there was no "on" delay which is required by the standard. CDRH has granted variances for systems that they specifically know do not have a power "on" delay. You are even a dealer for them. (This was discussed at SELEM.) Doesn't make them "illegal"... it just means that it deviates from the class standard and they (CDRH) are essentially saying: they know about it, they liked your answer and perhaps what other means you are using to make up for it and, have approved you varying from the standard.

I think for you to come out and say it's "illegal", you would need to actually have a copy of the product report submitted to the CDRH and know exactly what the manufacturer reported when they applied.

You are also sort of making the assumption that every weekend warrior DJ knows what makes a laser projector meet the standard and if the one they got is non-compliant to get rid of it or send it back or something. I am reasonably confident unless they are a laser geek and immerse themselves in the regs and be on this forum, that 98% are going to only know they bought a laser that has a variance number on the back, meaning they shouldn't be in trouble for using it properly. I don't suspect they all have the knowledge to check and test for all of that. (i.e. - Is the sticker the correct sticker? Is the variance sticker on the left on the back? etc. Did it turn back on after the power cord got knocked out or, did I have to do something to start it back up?)

If Able sells something substantially different to JD3 than what is in their filed product report, then yes, I heartily agree with you but, Able is the responsible party for certifying their projector. If they've got the paperwork, then they've got the paperwork. It's good to question of course and JD3 is to be commended for all the checking.

But "legal" boils down to: What the FDA will accept and, your quality assurance program. It has very little to do with the actual construction of the box itself. Yes, that's important as a part of the quality assurance program of course but, the question really is: Is this "thing" going to be compliant with the standard or whatever terms of the variance from the standard you are approved for, under any reasonably forseeable scenario or single failure condition. Yes, the standards are higher for a manufacturer such as yourself or Able, or LSDI or X-Laser or whoever (versus an individual certifying their own build) but, at the end of the day, "legal" is really whether it meets what the manufacturer told the FDA/CDRH it was going to meet.

(Love ya brotha'... Just shooting for some healthy discussion/education though.)

[polishedball]

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
"

Permits them to add models. Very cool that you dug into this info.

Is there a link to the wholesaler bringing them in?

[JD3]

I don't know of anyone importing them. I am dealing direct with Crystal in China.

Www.able-laser.com

[JD3]

Bradfo69,

This is what I have noticed in my findings. There is a list of things that MAY be done to a projector to make it "legal"
Not all of the list must be done. If you have A you must have B also. But if you have B you don't need C. If you have C you don't need A or B. Etc.