BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LASER PHOTOCOAGULATOR ARGON MED. LASER

    K Number: K813429 · Decision Jan 22, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    5
    Review Days
    45

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    Basic Information

    Device Name
    LASER PHOTOCOAGULATOR ARGON MED. LASER
    K Number
    K813429
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1360
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    American Laser Corp.
    Date Received
    December 8, 1981
    Decision Date
    January 22, 1982
    Product Code
    HPJ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HPJ Instrument, Visual Field, Laser

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