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510(k) Data Aggregation

    K Number
    K252028

    Validate with FDA (Live)

    Date Cleared
    2026-03-11

    (254 days)

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

    Prescription:
    LUOFUCON® Wound Gel Extra is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and superficial 2nd degree burns, partial and full thickness wounds and surgical incisions.

    OTC:
    LUOFUCON® Wound Gel Extra is indicated for the management minor cuts, minor lacerations, minor burns (1st degree burns), and abrasions.

    Device Description

    LUOFUCON® Wound Gel Extra is a clear, odorless, sterile amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. LUOFUCON® Wound Gel Extra is applied directly to the wound and then covered with an appropriate dressing. LUOFUCON® Wound Gel Extra contains high moisture content and can provide moisture to the wound. The use of LUOFUCON® Wound Gel Extra on a wound creates a moist environment that is conducive to healing. LUOFUCON® Wound Gel Extra can facilitate debridement through a moist wound environment. LUOFUCON® Wound Gel Extra provides preservative properties through benzalkonium chloride(BAC) to help inhibit the growth of microorganisms within the gel while in the tube.

    LUOFUCON® Wound Gel Extra is supplied in a tube (collapsible, polypropylene tube, sealed on one end and fitted with a screw cap on the other end).

    AI/ML Overview

    N/A

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