Results 1 to 9 of 9

Thread: ABLE LASER has FDA since 2009

  1. #1
    Join Date
    Mar 2014
    Posts
    68

    Default ABLE LASER has FDA since 2009

    ABLE LASER new FDA/CDRH accession number. We ABLE have FDA from 2009 and submit annual report each year. And we upgraded new models and comply with new rules in time. So pls stop to spread rumours to creat trouble for us ABLE. And the market competition is fair. The rumor will be debunked eventually. The market is for all. Play fair!
    Attached Thumbnails Attached Thumbnails FDA 2021.png  


  2. #2
    Join Date
    Jan 2006
    Location
    Charleston, SC
    Posts
    2,147,489,242

    Default

    I understand what you are trying to prove, but this letter is not helping your case.

    Anyone with a standard laser light show variance has to file an annual report, and when you file that report the CDRH sends you an acknowledgement letter with an accession number that looks exactly like the one you posted. So this letter doesn't prove anything beyond the fact that you've filed an annual report. We don't know the contents of that annual report, or even if it was an annual report for a laser manufacturer's variance or just for a laser light show variance.

    Instead, you might want to post a copy of the ACCEPTANCE letter where you were initially granted your laser product manufacturer's variance. That's proof that the CDRH has granted you permission to build and certify your laser products here in the USA.

    And if you *really* wanted to be thorough, you would also post a copy of the acknowledgement letter for the laser product report that you had to file for each of your laser projector models. That way people could verify that you had actually filed the laser product report.

    Note that just because you have a manufacturer's variance, that doesn't mean that your products are compliant. The manufacturer's variance simply gives you permission to produce the product; it's the laser product report that details the methods you've put in place to ensure your products comply with all regulations.

    Adam

    PS: I don't recall any recent threads here on the forum talking about the compliance of your products, so I'm wondering what triggered this post.?.

  3. #3
    Join Date
    Mar 2014
    Posts
    68

    Default Why I post this ?

    Hi,

    The reason why I post this is because someone told others we don't have FDA variance .

    In fact we got it for many years and we submit report every year.

    I show the initial letter we got below.
    Attached Thumbnails Attached Thumbnails ABLE LASER Variance Approval 2009V-0307.png  


  4. #4
    Join Date
    Dec 2007
    Location
    The West
    Posts
    1,281

    Default

    Thanks for posting this, I didnít know Ablelaser projectors were FDA certified!!
    i see thereís the variance and ascension number as well 👍
    RGB laser projectors
    Pangolin Beyond .NET
    APC40 Midi controllers
    Pangolin FB3 controllers
    DZ splitter
    LS MegaWatt Green Machine

  5. #5
    Join Date
    Jan 2006
    Location
    Charleston, SC
    Posts
    2,147,489,242

    Default

    Quote Originally Posted by carlos3621 View Post
    I see thereís the variance and ascension number as well 👍
    The variance number is the important part. The accession number is just a means of tracking the letter. All written communications from the CDRH will include an accession number, regardless of the content of the letter. (Dan Goldsmith used to joke that you could send a Christmas card to the CDRH and their reply to you would include an accession number! )

    Actually, there's another very important part of the acceptance letter, beyond the actual variance number itself. The crucial bit is in paragraph D, specifically - the second sentence: "The firm may also manufacturer, report, and certify class IIIb or class IV laser light show projectors under this variance." This is the part that demonstrates that they have a laser product manufacturer's variance, and not just a laser light show manufacturer's variance.

    One small nitpick though: The original post says that they've had their variance since 2009. But this acceptance letter is dated April 7, 2010. So in fact, they've had their variance since 2010, not 2009.

    Adam

  6. #6
    Join Date
    Mar 2014
    Posts
    68

    Default About ABLE LASER FDA

    Yes, we applied it in 2009 and got the formal letter in 2010.

    You can buy our lights with confidence.

  7. #7
    Join Date
    Apr 2009
    Location
    Seattle, WA
    Posts
    656

    Default

    I'm not sure where this is all coming from either, but as Adam stated, it just means you have your paperwork, not that you follow it with your builds. Case in point, I messaged you about a laser projector that a client brought in for repair and the Remote Interlock was not even soldered in, the laser started as soon as it was plugged in, and there key wasn't wired in either. The Key and Interlock port were there, but not connected to anything, and when I messaged your team about this, they said that they had started to connect those parts for the newer model but didn't have them connected in the earlier models.


    Quote Originally Posted by buffo View Post
    I understand what you are trying to prove, but this letter is not helping your case.

    Anyone with a standard laser light show variance has to file an annual report, and when you file that report the CDRH sends you an acknowledgement letter with an accession number that looks exactly like the one you posted. So this letter doesn't prove anything beyond the fact that you've filed an annual report. We don't know the contents of that annual report, or even if it was an annual report for a laser manufacturer's variance or just for a laser light show variance.

    Instead, you might want to post a copy of the ACCEPTANCE letter where you were initially granted your laser product manufacturer's variance. That's proof that the CDRH has granted you permission to build and certify your laser products here in the USA.

    And if you *really* wanted to be thorough, you would also post a copy of the acknowledgement letter for the laser product report that you had to file for each of your laser projector models. That way people could verify that you had actually filed the laser product report.

    Note that just because you have a manufacturer's variance, that doesn't mean that your products are compliant. The manufacturer's variance simply gives you permission to produce the product; it's the laser product report that details the methods you've put in place to ensure your products comply with all regulations.

    Adam

    PS: I don't recall any recent threads here on the forum talking about the compliance of your products, so I'm wondering what triggered this post.?.

  8. #8
    Join Date
    Mar 2014
    Posts
    68

    Default about ABLE LASER FDA

    Your analogy is very vivid.

    - - - Updated - - -

    Your analogy is very vivid.

  9. #9
    Join Date
    Jan 2006
    Location
    Charleston, SC
    Posts
    2,147,489,242

    Default

    Quote Originally Posted by slicklasers View Post
    it just means you have your paperwork, not that you follow it with your builds. Case in point, I messaged you about a laser projector that a client brought in for repair and the Remote Interlock was not even soldered in, the laser started as soon as it was plugged in, and there key wasn't wired in either.
    Yikes! That projector should never have been able to pass the QA/QC testing procedure that is REQUIRED before a laser projector is shipped to a customer. There's an entire section of the Laser Product Report that deals with the internal methods the manufacturer has in place to ENSURE that all products meet the requirements for certification.

    Based on the example above, I'd be very interested to see that portion of their product report! Although I agree that it's entirely possible that they are simply not following the process that is described in their product report. (Dishonest, yes, but entirely possible nonetheless.)

    when I messaged your team about this, they said that they had started to connect those parts for the newer model but didn't have them connected in the earlier models.
    That is not good enough. A laser product manufacturer is required to recall any non-compliant projectors that were sold and either bring those projectors into compliance before returning them to the customer, or destroy the old projector and supply a new, certified projector to the customer. All of this must be done at NO COST to the customer (not even shipping).

    If Able is aware that some of the products they have sold were non-compliant, they are obligated to recall them immediately. You said they admitted that their "earlier models" were non-compliant, but I haven't heard of any recalls... (Has the evidence of those non-compliant projectors been brought to the CDRH's attention? If not, it should be!)

    As an aside, this is exactly what lead to the demise of Laserworld USA. They knew they had sold a lot of non-compliant gear in the past, but they repeatedly delayed recalling those units. Eventually the CDRH revoked their manufacturer's variance.

    Adam

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •