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

    Q Switched Nd:YAG Laser machine (QNHF-01)

    K Number: K242943 · Decision Mar 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    2
    Review Days
    159

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    Basic Information

    Device Name
    Q Switched Nd:YAG Laser machine (QNHF-01)
    K Number
    K242943
    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 Nubway S&T Co., Ltd.
    Date Received
    September 25, 2024
    Decision Date
    March 3, 2025
    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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