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U.S. Department of Health and Human Services

Product Classification

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Device silicone hydrogel for scar management
Regulation Description Silicone sheeting.
Definition Management of closed hyperproliferative (hypertrophic and keloid) scars.
Physical State Silicone oil containing hydrogel with preservative identified by the Center for Drug Evaluation and Research (CDER) as an inactive ingredient.
Technical Method Product forms a protective film that helps maintain skin hydration.
Target Area Scars on the skin
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodePFP
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(k)
Regulation Number 878.4025
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible