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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
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ToeFX, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is a 510(k) clearance letter for the ToeFX, Inc. TFX-LT2000 Therapy Light, a Class II medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The information provided (the FDA clearance letter) focuses on regulatory aspects such as:

    • Confirmation of substantial equivalence to a predicate device.
    • Regulatory class and product code.
    • General controls and compliance requirements for medical devices.
    • Indications for Use statement.

    There is no mention of:

    • Specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy).
    • Any performance study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance).

    Therefore, I cannot fulfill your request for the detailed description of acceptance criteria and the study proving the device meets them based on the provided text. The document indicates regulatory clearance based on substantial equivalence, not detailed performance study data.

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