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Thread: Annual Reports

  1. #1
    Join Date
    Jul 2006
    Location
    Connecticut, USA
    Posts
    2,478

    Default Annual Reports

    Hey guys-

    For you USA laser folks that perform publically...

    annual reports are due, i think today.

    GET REPORT HERE

    and mail to:

    U.S. Food and Drug Administration
    Center for Devices and Radiological Heath
    Document Mail Center – WO66-G609
    10903 New Hampshire Avenue
    Silver Spring, MD 20993-0002

    You must do this every year now to have your variance renewed automatically. If ANYTHING about your projector changed (which would alter the original approval criteria), you must re submit your variance and light show report though.

    -Marc

    -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


  2. #2
    Join Date
    Mar 2010
    Location
    Seattle
    Posts
    150

    Default

    Hi gottaluvlasers

    Are you still using the report link above for the annual report due the Setp 1st 2010t?
    Slick Laser 2.4w RGB
    Omnisistem 1991 RG Q-Beam
    Hene Tube
    Shitty mistake Chauvet Scorpion fat beam

  3. #3
    Join Date
    Aug 2009
    Posts
    9

    Default

    I have a question about filling out the annual reports. it is written in a manner that is rather confusing. what sections do you fill out if you only perform shows and do not manufacture equipment? Sorry for my ignorance but want this to go through wo a problem
    Pro-Dynamics LLC

  4. #4
    Join Date
    Jun 2007
    Location
    Phoenix AZ
    Posts
    349

    Default

    " 15 characters"
    Last edited by Laser Wizardry; 11-13-2015 at 11:03.

  5. #5
    Join Date
    Jun 2007
    Location
    Phoenix AZ
    Posts
    349

    Default Now it's my turn for a dumb question

    " 15 characters"
    Last edited by Laser Wizardry; 11-13-2015 at 11:03.

  6. #6
    Join Date
    Aug 2009
    Posts
    9

    Default

    Well that makes sense. Thank you. I just started doing shows this year since I finally received my variance after a painfully long wait during which I filled out an annual report for a year which I had no shows due to the long period of waiting for the variance.
    Pro-Dynamics LLC

  7. #7
    Join Date
    Nov 2007
    Location
    SoCal / San Salvador / NY
    Posts
    4,018

    Lightbulb

    Quote Originally Posted by Laser Wizardry View Post
    For over a decade now I've been filling out my annual report to reflect the shows that actually happened, not the shows that I sent reports in for.
    Same here. If you really feel 'compelled', or, if they were to-ever actually ask about it (..which, I doubt they ever-will...) you could always put an * in the 'number produced'-section, and reference those shows that were 'reported, but not-performed' / why's, etc in a cover-letter or addendum-letter... Like they'll ever see it, once it crosses the 'event horizon' of Dale's desk... ..jk.. He's retiring-soon, anyway, God help us all.... I sure miss good-ol Frank Mac...

    Anyhoo, point-is, you've 'done yer part' - the rest - if-anything - is up to them... if thier bloody fax machine is down or mailroom burns-down, etc - Oh well - you 'CYA'd'...

    Hope this helps...
    j
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

  8. #8
    Join Date
    Nov 2009
    Location
    Maryland
    Posts
    320

    Default

    I'm with Jon. I don't think anyone is checking them THAT closely because there are bigger fish to fry. Do the right thing as best you can and all will be well. =)

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