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

    LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM

    K Number: K862598 · Decision Nov 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    59
    Applicant Total
    60
    Review Days
    141

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    Basic Information

    Device Name
    LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM
    K Number
    K862598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Laserscope
    Date Received
    July 1, 1986
    Decision Date
    November 19, 1986
    Product Code
    LNK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LNK Laser For Gastro-Urology Use

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