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510(k) Data Aggregation

    K Number
    K181074
    Device Name
    Simple Science Antimicrobial Facial and Eyelid Cleanser
    Manufacturer
    Simple Science LLC
    Date Cleared
    2018-08-17

    (115 days)

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

    Simple Science LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Over-the-Counter Use: For management of minor skin abrasions, minor lacerations, minor irritations, and intact skin of the face, eyelid and eyelashes.
    Device Description
    Simple Science Antimicrobial Facial & Eyelid Cleanser is a clear hypotonic solution topically applied to skin, eyelid and wound areas. The subject device is a wound management and cleansing solution that is intended for cleansing, irrigating, and debriding dermal wounds in addition to moistening and lubricating absorbent wound dressings (e.g. gauze). The mechanical action of fluid moving across the wound provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. Simple Science Antimicrobial Facial & Eyelid Cleanser contains the following ingredients: Ionized water (99.927%), Sodium chloride (0.06%), Hypochlorous acid (0.011%) and hypochlorite Ion (0.002%). Simple Science Antimicrobial Facial & Eyelid Cleanser will be supplied in 2 oz Glass bottle with spray inserts / caps.
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