# K252028: LUOFUCON® Antimicrobial Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Co., Ltd.
- Decided: Mar 11, 2026 after 254 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: 8 generations back to K914579 (1992). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163188: Next Science Wound Gel (Rx), Next Science, LLC (2017) Summary page 5.

## Indications for use
LUOFUCON® Wound Gel Extra is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and superficial 2nd degree burns, partial and full thickness wounds and surgical incisions. LUOFUCON® Wound Gel Extra is indicated for the management minor cuts, minor lacerations, minor burns (1st degree burns), and abrasions.

Source page: https://510kreport.com/device/K252028
Methodology: https://510kreport.com/methodology