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510(k) Data Aggregation

    K Number
    K180305
    Device Name
    Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
    Manufacturer
    Date Cleared
    2018-04-13

    (70 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Aquilabs US LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OTC Indications: Hychloderm Wound and Skin Care (OTC) is intended for over-the-counter use in the management of minor irritations, minor abrasions, minor burns, minor lacerations, and intact skin and lubrication absorbent wound dressings. Rx-only Indications: Hychloderm Wound and Skin Care (Rx) is intended for use by healthcare professionals for management of minor irritations, minor abrasions, minor lacerations, cleansing, irrigating, and debriding to remove wound debris from acute and chronic dermal or full thickness wound such as, stage I-IV pressure ulcers, diabetic foot ulcers, lst and 2nd degree burns, post-surgical wounds, and lubricating absorbent wound dressings.
    Device Description
    Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) are a single-patient single-use. clear liguid solution containing 0.01% hypochlorous acid (HOCI) as preservative in water/saline buffer, that aids the mechanical removal of debris and foreign material from the application site. Dirt, debris and foreign material is mechanically removed by the action of the wound cleanser moving across the wound bed or application site with or without the assistance of a suitable wound dressing (i.e. gauze). lt can be used in all stages of wound care and it is an ideal foundation for wound bed preparation. In addition to moistening and lubricating adsorbent wound dressings. It is a clear solution with 0.01% of hypochlorous acid that has been demonstrated to act as a preservative that inhibits microbial contamination within the solution.
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