Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K131672
    Device Name
    MICROCYN SCAR MANAGEMENT HYDROGEL
    Manufacturer
    OCULUS INNOVATIVE SCIENCES
    Date Cleared
    2013-11-15

    (162 days)

    Product Code
    PFP
    Regulation Number
    878.4025
    Why did this record match?
    Product Code :

    PFP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds. OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.
    Device Description
    Microcyn® Scar Management HydroGel is a translucent, silicone oil containing hydrogel which is intended for the management of old and new scars including hypertrophic and keloid scarring, on scars resulting from general surgical procedures, as well as trauma wounds, and burns. The product is intended to be applied to intact skin. The product is preserved with a unique mixture of hypochlorous acid and sodium hypochlorite generated through a proprietary process. The mixture of hypochlorous acid and sodium hypochlorite act as a preservative in the non-sterile product to inhibit microbial growth during storage and repeat use. The preservative is identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient based on the
    Ask a Question

    Page 1 of 1