# K173896: Microcyn Antimicrobial Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Sonoma Pharmaceuticals, Inc.
- Decided: Apr 2, 2018 after 101 days
- Product code: FRO (Dressing, Wound, Drug)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K914579 (1992). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153648: Microcyn Plus Skin and Wound Hydrogel, Oculus Innovative Sciences (2016) Summary page 4.
- K171935: Alevicyn SG Antimicrobial Gel, Sonoma Pharmaceuticals, Inc. (2017) Summary page 4.

## Indications for use
Rx: Under the supervision of a health care professional Microcyn Antimicrobial Hydrogel is intended for the management of post non ablative laser therapy procedures, post microdermabrasion therapy and following superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. OTC: Microcyn Antimicrobial Hydrogel is intended for the management of minor skin irritations following post non ablative laser therapy procedures, microdermabrasion therapy or superficial chemical peels. Microcyn Antimicrobial Hydrogel may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.

Source page: https://510kreport.com/device/K173896
Methodology: https://510kreport.com/methodology