510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131672Substantially Equivalent

Microcyn Scar Management Hydrogel

Sonoma Pharmaceuticals, Inc., Petaluma CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131672 is the FDA 510(k) clearance record for MICROCYN SCAR MANAGEMENT HYDROGEL, a class I device, cleared for Oculus Innovative Sciences on under FDA product code PFP (Silicone Hydrogel For Scar Management). FDA's definition for product code PFP reads: "Management of closed hyperproliferative (hypertrophic and keloid) scars". FDA records list 24 510(k) clearances for Sonoma Pharmaceuticals, Inc., from to . As of , FDA records show no recalls naming K131672.

Clearance record

Decision date
Received
(162 days to decision)
Product code
PFP Silicone Hydrogel For Scar Management
Regulation
21 CFR 878.4025
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Oculus Innovative Sciences 1129 N. Mcdowell Blvd., Petaluma CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFP

Trailing 12 months

FDA records hold no clearances under product code PFP in the trailing twelve months.

FDA records show no clearances under product code PFP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260