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510(k) Data Aggregation

    K Number
    K241116
    Device Name
    Onycho Laser V
    Manufacturer
    TerasysD&C Inc.
    Date Cleared
    2024-07-22

    (90 days)

    Product Code
    PDZ
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    TerasysD&C Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Onycho Laser V is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts, Candida albicans, etc.).
    Device Description
    The Onycho Laser V' is a compact device that is positioned on the floor and is operated via a 7.0 inch TFT touch screen for ease of use. The device incorporates lasers and outputs light at two wavelengths, 405 nm and 635 nm, in order to achieve its therapeutic effect.
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