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

    LASER-STIM

    K Number: K131259 · Decision Dec 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    25
    Review Days
    239

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    Basic Information

    Device Name
    LASER-STIM
    K Number
    K131259
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Shenzhen Dongdixin Technology Co., Ltd.
    Date Received
    May 2, 2013
    Decision Date
    December 27, 2013
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

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