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

    Q-Switched Nd:YAG Laser Therapy Systems

    K Number: K163123 · Decision Feb 2, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    2
    Review Days
    86

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    Basic Information

    Device Name
    Q-Switched Nd:YAG Laser Therapy Systems
    K Number
    K163123
    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
    Beijing Sincoheren Science and Technology Development Co.
    Date Received
    November 8, 2016
    Decision Date
    February 2, 2017
    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 Beijing Sincoheren Science and Technology Development Co.

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