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

    Dawn Diode Laser System

    K Number: K232885 · Decision Feb 28, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    16
    Applicant Total
    6
    Review Days
    163

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    Basic Information

    Device Name
    Dawn Diode Laser System
    K Number
    K232885
    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
    Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
    Date Received
    September 18, 2023
    Decision Date
    February 28, 2024
    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 Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

    K Number Device Name
    K243037 Diode Laser System model Dawn-S
    K222265 Diosculpt
    K183122 810nm Diode Laser System
    K163655 Sparkling
    K161356 Matrix LS-40 CO2 Laser System