# K153648: Microcyn Plus Skin and Wound Hydrogel

- Pathway: 510(k) (Traditional)
- Applicant: Oculus Innovative Sciences
- Decided: Apr 19, 2016 after 120 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: 5 generations back to K830708 (1983). 13 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093585: Microcyn Skin and Wound Hydrogel, Oculus Innovative Sciences, Inc. (2010) Summary page 4.
- K090092: Sockit! and Mcmerlin Dermal Wound Gel, Mcmerlin Dental Products LP (2009) Summary page 4.

## Most influential descendants
- K173549: Biafine (2018), 4 descendants of its own
- K232655: Bonvadis® (2024), 2 descendants of its own
- K251093: Bonvadis® (2025), 1 descendant of its own
- K261638: Bonvadis® (2026), 0 descendants of its own
- K190342: BIAFINE Topical Cream (2019), 0 descendants of its own

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

Source page: https://510kreport.com/device/K153648
Methodology: https://510kreport.com/methodology