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510(k) Data Aggregation

    K Number
    K232177
    Device Name
    Lightin System, Lightin, Lightin Generator
    Manufacturer
    Solmedix Co., Ltd
    Date Cleared
    2024-07-10

    (352 days)

    Product Code
    SBS, EQH
    Regulation Number
    874.4420
    Why did this record match?
    Product Code :

    SBS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lightin is a needle for injection laryngoplasty with an optical fiber. Lightin Generator is an AC-powered light source including Light Guide which is fiber optic cable that transmits light at the tip of fiber optics embedded within Lightin. Lightin System is used for injection laryngoplasty to address glottic incompetence to indicate the injection site with visible light.
    Device Description
    Lightin System consists of Lightin and Lightin Generator. Lightin is a light-guided needle used injection laryngoplasty and Light generator delivers the light energy to Lightin by generating LED light from an AC-powered light source. Lighin consists of injection needle, Y-connector and SMA connector/cable. The light transmitted from the Lightin Generator is emitted from the tip of fiber optics embedded within Lightin. Lightin system used for injection laryngoplasty procedures to indicate the injection site with visible light. This system does not contain or deliver drugs.
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