BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Powersculp laser lipolysis system

    K Number: K191068 · Decision Jul 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    18
    Applicant Total
    5
    Review Days
    86

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    Basic Information

    Device Name
    Powersculp laser lipolysis system
    K Number
    K191068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Wuhan Lotuxs Technology Co., Ltd.
    Date Received
    April 22, 2019
    Decision Date
    July 17, 2019
    Product Code
    PKT
    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
    PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use

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