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

    GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C

    K Number: K091664 · Decision Nov 16, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    73
    Applicant Total
    7
    Review Days
    160

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    Basic Information

    Device Name
    GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C
    K Number
    K091664
    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
    Shenzhen Gsd Tech Co., Ltd.
    Date Received
    June 9, 2009
    Decision Date
    November 16, 2009
    Product Code
    ONF
    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
    ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

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