PFP — Silicone Hydrogel For Scar Management Class I
FDA product code PFP covers "Silicone Hydrogel For Scar Management", a Class I medical device regulated under 21 CFR 878.4025. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PFP
- Device Class
- Class I
- Regulation Number
- 878.4025
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Management of closed hyperproliferative (hypertrophic and keloid) scars.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K131672 | oculus innovative sciences | MICROCYN SCAR MANAGEMENT HYDROGEL | November 15, 2013 |