BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA

    K Number: K001772 · Decision Jul 6, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    60
    Registration Numbers
    61
    Same Product Code
    179
    Applicant Total
    1
    Review Days
    24

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    Basic Information

    Device Name
    LASEREX ERA ARTICULATED ARM KIT, MODEL LQP4106-AA
    K Number
    K001772
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.4390
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Taracan Pty. , Ltd.
    Date Received
    June 12, 2000
    Decision Date
    July 6, 2000
    Product Code
    HQF
    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
    HQF Laser, Ophthalmic

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