FDA product code PFP: Silicone Hydrogel For Scar Management
PFP is the FDA product code for silicone hydrogel for scar management. It is a Class I device, regulated under 21 CFR 878.4025 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under PFP. The average 510(k) review took 162 days (median 162).
Definition
Management of closed hyperproliferative (hypertrophic and keloid) scars.
Classification
| Field | Value |
|---|---|
| Device name | Silicone Hydrogel For Scar Management |
| Device class | Class I |
| Regulation | 21 CFR 878.4025 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every PFP clearance
Top PFP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oculus Innovative Sciences | 1 | 2013-11-15 |
Most recent PFP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131672 | Oculus Innovative Sciences | MICROCYN SCAR MANAGEMENT HYDROGEL | 2013-11-15 | 162 |
Recalls for PFP devices
openFDA lists no recalls for product code PFP.
Frequently asked questions
What is FDA product code PFP?
PFP is the FDA product code for silicone hydrogel for scar management. It is a Class I device, regulated under 21 CFR 878.4025 and reviewed by the General and Plastic Surgery panel.
What device class is PFP?
Class I, regulation 21 CFR 878.4025. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code PFP?
Across 1 cleared submissions the average was 162 days from receipt to decision (median 162).
Which companies have the most PFP clearances?
Oculus Innovative Sciences (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PFP
- Run a recall and safety report across every PFP manufacturer
- Watch product code PFP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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