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510(k) Data Aggregation

    K Number
    K250642
    Date Cleared
    2025-11-19

    (260 days)

    Product Code
    Regulation Number
    N/A
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Prescription Use:
    LUOFUCON® Skin and Wound cleanser is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.

    OTC Use:
    LUOFUCON® Skin and Wound cleanser is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.

    Device Description

    LUOFUCON® Skin and Wound Cleanser is a clear, colorless solution with a mild odor. It helps in the mechanical removal of debris and foreign materials from the skin, wounds, or application sites. This product contains 0.1% w/w polyhexamethylene biguanide (PHMB) as a preservative, which helps inhibit the growth of microorganisms in the solution.

    LUOFUCON® Skin and Wound Cleanser is available in various packaging forms, such as Spray, Mist, Squeeze, and Bottle models. They can be suited for different clinical situations.

    AI/ML Overview

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