Cleared Traditional

LUOFUCON SILVER FOAM DRESSING

K141619 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery
Apr 2015
Decision
293d
Days
—
Risk

About This 510(k) Submission

K141619 is an FDA 510(k) clearance for the LUOFUCON SILVER FOAM DRESSING, a Dressing, Wound, Drug, submitted by Huizhou Foryou Medical Devices Co., Ltd. (New Milford, US). The FDA issued a Cleared decision on April 6, 2015, 293 days after receiving the submission on June 17, 2014. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K141619 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2014
Decision Date April 06, 2015
Days to Decision 293 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class —

Similar Devices — FRO Dressing, Wound, Drug

All 698
Promogran Prisma? Collagen Matrix with ORC and Silver
K251999 · Solventum Germany GmbH · Mar 2026
LUOFUCON? Antimicrobial Wound Gel
K252028 · Huizhou Foryou Medical Co., Ltd. · Mar 2026
Redermax Antibacterial Wound Matrix
K251582 · Beijing Kreate Medical Co., Ltd. · Feb 2026
New Day Skin Spray
K252568 · Silk Holdings, Inc. · Jan 2026
SBC1 Cream
K250890 · Sioxmed, LLC · Jan 2026
revyve? Antimicrobial Skin and Wound Cleanser
K252759 · Kane Biotech, Inc. · Jan 2026

More from Huizhou Foryou Medical...

View all
LUOFUCON? Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
K250642 · FRO · Nov 2025
LUOFUCON? Silver Collagen Dressing
K240809 · FRO · Dec 2024
LUOFUCON? Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON? Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
K242856 · FRO · Nov 2024
LUOFUCON? Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON? Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
K240485 · FRO · Oct 2024
LUOFUCON? Collagen Particles (Collagen Wound Dressing)
K232796 · KGN · Apr 2024