# K223359: LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Dec 21, 2023 after 413 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: 7 generations back to K914579 (1992). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140954: Luofucon Silver PU Antibacterial Foam Dressing, Huizhou Foryou Medical Devices Co., Ltd. (2015) Summary page 4.
- K083133: Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam Dressings, Andover Healthcare, Inc. (2009) Summary page 5.

## Indications for use
LUOFUCON® Ag+ Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds, including leg and foot ulcers, pressure ulcers, diabetic foot ulcers, superficial second-degree burns, donor sites, surgical wounds, lacerations and abrasions. LUOFUCON® Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor lacerations, minor scrapes, minor scalds and minor burns.

Source page: https://510kreport.com/device/K223359
Methodology: https://510kreport.com/methodology