# K254256: LUOFUCON® Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Aug 18, 2026 after 232 days
- Product code: QSZ (Absorbable Synthetic Wound Dressing)
- 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 K842066 (1985). 82 ancestors in all.
No later device cites it as a predicate yet.
0 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170300: Restrata Wound Matrix, Acera Surgical, Inc. (2017) Summary page 5.

## Indications for use
LUOFUCON® Wound Matrix is indicated to cover and protect a wound. LUOFUCON® Wound Matrix is intended for the management of: partial and full-thickness wounds, partial thickness burns, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, skin tears), draining wounds. LUOFUCON® Wound Matrix is intended for adults except for those who are allergic to poly(lactic-co-glycolic acid) or polyethylene glycol.

Source page: https://510kreport.com/device/K254256
Methodology: https://510kreport.com/methodology