# K240809: LUOFUCON® Silver Collagen Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Dec 16, 2024 after 266 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 K071552 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071552: Puracol Plus AG Collagen Microscaffold Wound Dressing, Medline Industries, Inc. (2008) Summary page 5.

## Indications for use
LUOFUCON® Silver Collagen Dressing is intended for the management of wounds that include: Full thickness and partial thickness wounds Pressure ulcers venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers First and second degree burns Donor sites and other bleeding surface wounds Abrasions Trauma wounds healing by secondary intention Dehisced wounds Surgical wounds Dehisced surgical wounds

Source page: https://510kreport.com/device/K240809
Methodology: https://510kreport.com/methodology