Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4025](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4025) → PFP — Silicone Hydrogel For Scar Management

# PFP · Silicone Hydrogel For Scar Management

_General, Plastic Surgery · 21 CFR 878.4025 · Class 1_

**Canonical URL:** https://fda.innolitics.com/productcode/PFP

## Overview

- **Product Code:** PFP
- **Device Name:** Silicone Hydrogel For Scar Management
- **Regulation:** [21 CFR 878.4025](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4025)
- **Device Class:** 1
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## 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.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K131672](/device/K131672.md) | MICROCYN SCAR MANAGEMENT HYDROGEL | Oculus Innovative Sciences | Nov 15, 2013 | SESE |

## Top Applicants

- Oculus Innovative Sciences — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/PFP](https://fda.innolitics.com/productcode/PFP)

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