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510(k) Data Aggregation

    K Number
    K990651
    Device Name
    SKIN 2 FORTE SILICONE SHEETING
    Date Cleared
    1999-08-13

    (165 days)

    Product Code
    Regulation Number
    878.4025
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNITED HOSPITAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SKIN 2 forté Silicone Sheeting is indicated for the management of hypertrophic and keloid scars. Consistent use of SKIN 2 forte can reduce hypertrophic and keloid scars. SKIN 2 forté may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic and keloid scars. SKIN 2 forté may be used as soon as the wound is closed, dry and the sutures or staples have been removed.
    Device Description
    Skin 2 forté Silicone Sheeting is a non-surgical, medically proven product that can help reduce your old scars and prevent new scars from developing. Skin 2 forté softens, smoothes and flattens scar tissue and restores a more normal skin color and texture. Consistent use of the SKIN 2 forté system can reduce hypertrophic and keloid scars.
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