# K211123: LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Apr 22, 2022 after 372 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: 1 generation back to K083103 (2009). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083103: Acryderm Antimicrobial Silver Gel Wound Dressing Model #B, Acrymed, Inc. (2009) Summary page 4.

## Most influential descendants
- K251929: SilverCeuticals® Antimicrobial Wound Gel (2026), 0 descendants of its own

## Indications for use
Prescription: LUOFUCON® Silver Wound Gel is under the medical supervision of a healthcare professional for the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites, and donor sites. OTC: LUOFUCON® Silver Antimicrobial Wound Gel is indicated for the topical management of minor abrasions, minor cuts, minor lacerations and minor burns.

Source page: https://510kreport.com/device/K211123
Methodology: https://510kreport.com/methodology