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

    LYSONIX LIPOPLASTY ACCESS PORT

    K Number: K980763 · Decision May 28, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    57
    Applicant Total
    5
    Review Days
    90

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    Basic Information

    Device Name
    LYSONIX LIPOPLASTY ACCESS PORT
    K Number
    K980763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lysonix, Inc.
    Date Received
    February 27, 1998
    Decision Date
    May 28, 1998
    Product Code
    QPB
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QPB System, Suction, Lipoplasty For Removal

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    Other Clearances by Lysonix, Inc.

    K Number Device Name
    K980771 LYSONIX SUCTION LIPOPLASTY SYSTEM
    K980454 LYSONIX ASPIRATION PUMP
    K974233 LYSONIX IRRIGATION SYSTEM
    K972958 LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND CANNULAS