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510(k) Data Aggregation
K Number
K131672Device Name
MICROCYN SCAR MANAGEMENT HYDROGEL
Manufacturer
OCULUS INNOVATIVE SCIENCES
Date Cleared
2013-11-15
(162 days)
Product Code
PFP
Regulation Number
878.4025Why 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
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