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510(k) Data Aggregation

    K Number
    K211265
    Device Name
    TFX-LT2000 Therapy Light
    Manufacturer
    ToeFX, Inc.
    Date Cleared
    2022-11-17

    (570 days)

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

    ToeFX, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TFX-LT2000 Therapy Light device is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
    Device Description
    Not Found
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