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

    Q-SWITCHED ND:YAG LASER

    K Number: K131857 · Decision Jan 16, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    5
    Review Days
    206

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    Basic Information

    Device Name
    Q-SWITCHED ND:YAG LASER
    K Number
    K131857
    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 Honkon Technologies Co., Ltd.
    Date Received
    June 24, 2013
    Decision Date
    January 16, 2014
    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 Honkon Technologies Co., Ltd.

    K Number Device Name
    K161892 Slimming Treatment Device
    K131838 DIODE LASER FOR HIAR REMOVAL
    K131837 CO2 FRACTIONAL LASER
    K131859 MULTIFUNCTIONAL SERIES