# K242856: LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)

- Pathway: 510(k) (Special)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Nov 13, 2024 after 54 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: 10 generations back to K914579 (1992). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223360: LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing, Huizhou Foryou Medical Devices Co., Ltd. (2024) Summary page 5.

## Indications for use
LUOFUCON® Silicone 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, 1st and 2nd degree burns, donor sites, traumatic and surgical wounds, lacerations and abrasions. LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing is indicated for first aid management of minor abrasions, minor cuts, minor scrapes, minor scalds and minor burns.

Source page: https://510kreport.com/device/K242856
Methodology: https://510kreport.com/methodology