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510(k) Data Aggregation

    K Number
    K253960

    Validate with FDA (Live)

    Device Name
    Medicell Mycosis Laser (MCML24004)
    Manufacturer
    Medicell Healthcare Co.,LTD
    Date Cleared
    2026-03-09

    (89 days)

    Product Code
    PDZ
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K221363
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Medicell Mycosis Laser is indicated for the temporary increase of clear nails in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum, and T. mentagrophytes, and/or yeasts Candida albicans, etc.)

    Device Description

    The Medicell Mycosis Laser is a medical laser used to treat nail fungus (onychomycosis). The device produces two wavelengths of light, 635nm and 405nm, to produce a photochemical reaction to achieve its therapeutic effects. The Mycosis laser is a compact, all-in-one device that is intended to be used on the floor and is operated by an intuitive touch screen for ease of use. An LCD monitor incorporated into the face of the device helps the operator check the exact location of treatment area during a procedure.

    AI/ML Overview

    N/A

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