# K131672: Microcyn Scar Management Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences
- Decided: Nov 15, 2013 after 162 days
- Product code: PFP (Silicone Hydrogel For Scar Management)
- Device class: 1
- Regulation: 21 CFR 878.4025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K002488 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002488: Kelo-Cote Topical Gel, Advanced Bio-Technologies, Inc. (2001) Summary page 1.
- K083718: Beau RX Scar Care Gel, Beau RX Solutions, LLC (2009) Summary page 1.

## Indications for use
Rx INDICATIONS: Under the supervision of a health care professional, Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds. OTC INDICATIONS: Microcyn® Scar Management HydroGel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Source page: https://510kreport.com/device/K131672
Methodology: https://510kreport.com/methodology