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

    980nm Diode Laser Therapy Device

    K Number: K191349 · Decision Aug 16, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    14
    Review Days
    88

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    Basic Information

    Device Name
    980nm Diode Laser Therapy Device
    K Number
    K191349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shanghai Apolo Medical Technology Co., Ltd.
    Date Received
    May 20, 2019
    Decision Date
    August 16, 2019
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Shanghai Apolo Medical Technology Co., Ltd.

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