BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇰🇷 South Korea

    Lightin System, Lightin, Lightin Generator

    K Number: K232177 · Decision Jul 10, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    352

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    Basic Information

    Device Name
    Lightin System, Lightin, Lightin Generator
    K Number
    K232177
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Solmedix Co., Ltd.
    Date Received
    July 24, 2023
    Decision Date
    July 10, 2024
    Product Code
    SBS
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    SBS Laryngeal Injection Set With Led Light