Definition: Management Of Closed Hyperproliferative (hypertrophic And Keloid) Scars.
| Device Type ID | 5862 |
| Device Name | Silicone Hydrogel For Scar Management |
| 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 Description | Silicone Sheeting. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| 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) Exempt |
| CFR Regulation Number | 878.4025 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PFP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5862 |
| Device | Silicone Hydrogel For Scar Management |
| Product Code | PFP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Silicone Sheeting. |
| CFR Regulation Number | 878.4025 [🔎] |