FDA.reportPublic FDA data

510(k) K254256

Device
LUOFUCON® Wound Matrix
Applicant
Huizhou Foryou Medical Devices Co., Ltd.
510(k) number
K254256
Product code
QSZ
Decision
Substantially Equivalent (SESE)
Decision date
2026-08-18
Date received
2025-12-29
Classification name
Absorbable Synthetic Wound Dressing
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Ni Zhan
Address
North Shangxia Rd. Dongjiang Hi-Tech Industry Park Huizhou CN 516005 516005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QSZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261311HYALOMATRIXAnika Therapeutics, Inc.2026-09-02
K260020Redermo Wound MatrixBeijing Kreate Medical Co., Ltd.2026-04-16
K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd.2025-06-20
K242149NovoSorb® MTXPolynovo Biomaterials Pty, Ltd.2025-03-05
K241660SiOxD® Wound MatrixSioxmed, LLC2024-07-05
K232847SiOxD Wound MatrixSioxmed, LLC2023-12-18
K223725Restrata® MiniMatrixAcera Surgical, Inc.2023-05-18
K222189SiOxD Wound MatrixSioxmed, LLC2022-11-18
K221686NovoSorb MatrixPolynovo Biomaterials Pty, Ltd.2022-09-15
K193583Restrata®Acera Surgical, Inc.2020-09-25
K173544Phoenix Wound MatrixNanofiber Solutions, Inc.2018-03-02
K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm)Polynovo Biomaterials Pty, Ltd.2017-08-11
K170213SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH2017-06-28
K170300Restrata Wound MatrixAcera Surgical, Inc.2017-04-26
K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”Engineered Tissue Solutions, LLC2016-09-15