510(k) clearance

LUOFUCON® Wound Matrix

FDA 510(k) source

510(k) number

K254256

Applicant

Huizhou Foryou Medical Devices Co., Ltd.

Decision date

Aug 18, 2026

Date received

Dec 29, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QSZ

Device type

Absorbable Synthetic Wound Dressing

Device class

Unclassified

Advisory committee

Unknown

Statement or summary

Summary

Third party

N

Location

Huizhou, CN