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510(k) Data Aggregation
K Number
K990651Device Name
SKIN 2 FORTE SILICONE SHEETING
Manufacturer
Date Cleared
1999-08-13
(165 days)
Product Code
Regulation Number
878.4025Why 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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