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

    Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

    K Number: K243764 · Decision May 8, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    16
    Applicant Total
    7
    Review Days
    153

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    Basic Information

    Device Name
    Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
    K Number
    K243764
    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
    Wuhan Pioon Technology Co., Ltd.
    Date Received
    December 6, 2024
    Decision Date
    May 8, 2025
    Product Code
    NVK
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    NVK Laser, Dental, Soft Tissue

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    Other Clearances by Wuhan Pioon Technology Co., Ltd.

    K Number Device Name
    K250656 Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
    K240747 Medical Diode Laser (M2-GK)
    K240644 Medical Diode Laser (S1Pro)
    K240179 Medical Diode Laser (Model: L2)
    K231548 Medical Diode Laser, Model S1Pro
    K230274 Medical Diode Laser (M2)