# K240485: LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Oct 7, 2024 after 230 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: 6 generations back to K914604 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210718: LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing, Huizhou Foryou Medical Devices Co., Ltd. (2022) Summary page 5.

## Indications for use
Prescription: Under the supervision of a healthcare professional: LUOFUCON® Extra Silver Gelling Fiber Dressing Plus may be used for the management of moderate to heavily exuding chronic and acute wounds as an effective barrier to bacterial penetration of the dressing, including: Partial thickness burns (second degree); Diabetic foot ulcers; Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology); Pressure ulcers (partial and full thickness); Donor sites; Surgical wounds; Traumatic wounds. OTC: LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus may be used for: Minor abrasions; Minor lacerations; Minor cuts; Minor scalds and burns.

Source page: https://510kreport.com/device/K240485
Methodology: https://510kreport.com/methodology