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

    Diode Laser Body Sculpture System

    K Number: K201731 · Decision Sep 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    18
    Applicant Total
    14
    Review Days
    78

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    Basic Information

    Device Name
    Diode Laser Body Sculpture System
    K Number
    K201731
    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
    Shanghai Apolo Medical Technology Co., Ltd.
    Date Received
    June 24, 2020
    Decision Date
    September 10, 2020
    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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