Results 1 to 3 of 3

Thread: medical laser variance ?

  1. #1
    Join Date
    Mar 2008
    Location
    lawton ok
    Posts
    91

    Laser Warning medical laser variance ?

    is it possible to get the same variance with a medical laser as say another usa made laser ? it would have a number on file already with the fda am i not correct?

  2. #2
    Join Date
    Nov 2007
    Location
    SoCal / San Salvador / NY
    Posts
    4,018

    Lightbulb

    hi b52 -

    Quote Originally Posted by b52productions View Post
    is it possible to get the same variance with a medical laser as say another usa made laser ? it would have a number on file already with the fda am i not correct?
    Not trying to sound like a smartass, but.. What, exactly, are you trying to 'accomplish', here? Assuming you're Not trying to get a Medical Product, varianced, correct? Cause that's a whooole different mountain, mon freré.. Same basic 'process', mucho Mucho mas complicado / layered / detailed...

    ...but, if you're trying to get / amend a Show Variance, using a 'medical laser' as a source, only (ie: an Argon or KTP, etc..) That's pretty easy - Unless - you are either a) modifying the safety-controls / beam-paths of said-source (thereby invalidating any Certification it has, as a source..) or b) incorporating it Into a product, you were, then, going to 'market' / sell 'As a product' of You, Inc. (not just 'doing a Show using a med-laser source'..)

    ...also assuming this Is Visible light we're talking, right? Cause pretty much 'invisible wavelength laser shows' are Also gonna be a 'constipated juggernaut', at best..

    Lettuce know..
    j
    ....and armed only with his trusty 21 Zorgawatt KTiOPO4...

  3. #3
    mixedgas's Avatar
    mixedgas is offline Creaky Old Award Winning Bastard Technologist
    Infinitus Excellentia Ion Laser Dominatus
    Join Date
    May 2007
    Location
    A lab with some dripping water on the floor.
    Posts
    9,665

    Default

    You do have to de-medicalize it a bit, remove the handpiece, ditch the exposure control software, etc... At least that is what I had to do..
    Somehow render it reasonably unfit for medical service, then document the function of the safety features that you kept.
    ~
    401K approval for a medical device, well the design and quality control paperwork could fill phonebooks. The process is similar, but the work is far more detailed and vast.



    Steve
    Qui habet Christos, habet Vitam!
    I should have rented the space under my name for advertising.
    When I still could have...

Posting Permissions

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