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510(k) K210718

Device
LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
Applicant
Huizhou Foryou Medical Devices Co., Ltd.
510(k) number
K210718
Product code
FRO  
Decision
Substantially Equivalent (SESE)
Decision date
2022-03-23
Date received
2021-03-10
Regulation
510(k) Premarket Notification
Classification name
Dressing, Wound, Drug
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
General & Plastic Surgery
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Junfeng Zhang
Address
North Shangxia Rd., Dongjiang Hi-Tech Industrial Park Huizhou CN 516005 516005

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FRO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254073StatSeal DiscMerit Medical Systems, Inc.2026-05-13
K254191IWD-Gel™InnovaCorium, Inc.2026-04-07
K252023MiraChlor Antimicrobial Wound SolutionLetus Corporation2026-03-25
K251999Promogran Prisma™ Collagen Matrix with ORC and SilverSolventum Germany GmbH2026-03-13
K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd.2026-03-11
K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.2026-02-02
K252568New Day Skin SpraySilk Holdings, Inc.2026-01-23
K250890SBC1 CreamSioxmed, LLC2026-01-12
K252759revyve® Antimicrobial Skin and Wound CleanserKane Biotech, Inc.2026-01-08
K251757Puracyn® Plus Antimicrobial Irrigation SolutionInnovacyn, Inc.2026-01-05
K252167Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)Qingdao Bright Moon Biomedical Materials Co., Ltd.2025-12-19
K250642LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)Huizhou Foryou Medical Devices Co., Ltd.2025-11-19
K250115Hemastyl(™) Wound DressingRapid Nexus Nanotech Wound Solutions, Inc.2025-10-14
K251866Tegaderm Post-Op Transparent Antimicrobial DressingSolventum US, LLC2025-10-10
K243166DermalageInfection Elimination Solutions, LLC2025-08-27

Legacy Summary#

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FDA Review#

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