# K141619: Luofucon Silver Foam Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Apr 6, 2015 after 293 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: 4 generations back to K000051 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110062: Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AG, Medipurpose Pte., Ltd. (2011) Summary page 4.

## Indications for use
The Luofucon Silver Foam Dressing is indicated for exudate absorption and the management of partial to full thickness wounds. Some typical wounds are: • Ulcers (venous, arterial, diabetic) • Pressure Sores • Donor Sites • Surgical Incisions • Surgical Excisions • Burns (1st and 2nd degree)

Source page: https://510kreport.com/device/K141619
Methodology: https://510kreport.com/methodology