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

    LASER IRAS

    K Number: K853556 · Decision Nov 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    67

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    Basic Information

    Device Name
    LASER IRAS
    K Number
    K853556
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1360
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Randwal Instrument Co., Inc.
    Date Received
    August 26, 1985
    Decision Date
    November 1, 1985
    Product Code
    HPJ
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    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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    Other Clearances by Randwal Instrument Co., Inc.

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