PFP · Silicone Hydrogel For Scar Management
General, Plastic Surgery · 21 CFR 878.4025 · Class 1
Overview
| Product Code | PFP |
|---|---|
| Device Name | Silicone Hydrogel For Scar Management |
| Regulation | 21 CFR 878.4025 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
Silicone sheeting is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131672 | MICROCYN SCAR MANAGEMENT HYDROGEL | Oculus Innovative Sciences | Nov 15, 2013 | SESE |
Top Applicants
- Oculus Innovative Sciences — 1 clearance
