Product code PFP

Device name

Silicone Hydrogel For Scar Management

Medical specialty

General, Plastic Surgery

Device class

1

Regulation number

878.4025

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Management of closed hyperproliferative (hypertrophic and keloid) scars.

Source

FDA openFDA device classification dataset