DeviceClearance

Product code PFP— General, Plastic Surgery

MICROCYN SCAR MANAGEMENT HYDROGEL

Classification name
Silicone Hydrogel For Scar Management
Device class
Class 1
Regulation
21 CFR 878.4025
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

“Management of closed hyperproliferative (hypertrophic and keloid) scars.”

— U.S. Food and Drug Administration, device classification record for product code PFP under 21 CFR 878.4025, via openFDA

Market context for product code PFP

FDA has cleared 1 device under product code PFP, all in 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code PFP

Recent clearances under product code PFP

Data sourced from openFDA. This site is unofficial and independent of the FDA.