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

    Medical Diode Laser Systems

    K Number: K230047 · Decision Mar 4, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    16
    Applicant Total
    4
    Review Days
    423

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    Basic Information

    Device Name
    Medical Diode Laser Systems
    K Number
    K230047
    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
    Gigaalaser Company , Ltd.
    Date Received
    January 6, 2023
    Decision Date
    March 4, 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 Gigaalaser Company , Ltd.

    K Number Device Name
    K242755 Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
    K250018 Medical Diode Laser Systems (THEIA808)
    K241791 Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)