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Thread: CDRH certification question

  1. #1
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    Default CDRH certification question

    I see that one stop laser shop sells CDRH Certified Projector Base what exactly does this mean? by using this does this mean u can get a variance easier?

  2. #2
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    "Laser operator"- The laser gods, will be with you, in just one moment ! ''Musak''
    " MANUFACTURER OF HIGH QUALITY MICRO LASER COMPONENTS" !!
    http://www.microlaserlabs.com/

  3. #3
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    Quote Originally Posted by Shawnb View Post
    I see that one stop laser shop sells CDRH Certified Projector Base what exactly does this mean? by using this does this mean u can get a variance easier?

    Yes, I think it means exactly that.

  4. #4
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    Hi Shawnb-

    Yes, it will be easier. Becasue you are already using a certified case, there will b eno need to produce a product report.

    You still need to prepare the laser light show report, and complete the Variance application.

    -Marc
    http://www.laserist.org/images/ildalogos/ILDA-logo_colored-beams_Corporate_150w.jpg

    ILDA- U.S. Laser Regulatory Committee

    Authorized Dealer for:

    • Pangolin Laser Software and Hardware
    • KVANT Laser Modules & Laser Systems
    • X-Laser USA
    • CNI Lasers
    • Cambridge Technology & Eye Magic Professional Scanning Systems

    FDA/CDRH Certified Professional LuminanceRGB Laser Light Show Systems


  5. #5
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    Cool

    Quote Originally Posted by gottaluvlasers View Post
    there will b eno need to produce a product report.
    I think you still have to fill out an amended product report, don't you? Because you are modifying the product... Granted, it still makes the process easier, since you only detail the stuff you change, but I don't think you're exempted from filing...

    Adam

  6. #6
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    There's a bit of useful info on CDRH certifications and obtaining a variance here:

    http://photonlexicon.com/forums/showthread.php?t=9394

  7. #7
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    Quote Originally Posted by buffo View Post
    I think you still have to fill out an amended product report, don't you? Because you are modifying the product... Granted, it still makes the process easier, since you only detail the stuff you change, but I don't think you're exempted from filing...

    Adam
    Hey Adam-

    no, an amendment will not be needed becasue there is no modification of the original approved standards to the LT1000.

    Unless someone incorporates a product or deviation into the LT1000 that wasn't already covered in its MANY ammendments over the years, than there is no need for a product report submission.

    If, for example, someone figured out a way to get 40W KTP inside of an LT1000, then at that point, a new product report would need to be filed because the current variance does not provide an approaval for this type of laser.

    If someone changed the optical base plate, or took out the shutter, or added onto the projector (made it bigger), these would all be considered modifications and therefore would need to be amended.

    -Marc
    http://www.laserist.org/images/ildalogos/ILDA-logo_colored-beams_Corporate_150w.jpg

    ILDA- U.S. Laser Regulatory Committee

    Authorized Dealer for:

    • Pangolin Laser Software and Hardware
    • KVANT Laser Modules & Laser Systems
    • X-Laser USA
    • CNI Lasers
    • Cambridge Technology & Eye Magic Professional Scanning Systems

    FDA/CDRH Certified Professional LuminanceRGB Laser Light Show Systems


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