Cleared Traditional

K211123 - LUOFUCON Silver Wound Gel

K211123 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device
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Apr 2022
Decision
372d
Days
-
Risk

K211123 is an FDA 510(k) clearance for the LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on April 22, 2022 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Huizhou Foryou Medical Devices Co., Ltd. devices

Submission Details

510(k) Number K211123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2021
Decision Date April 22, 2022
Days to Decision 372 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
257d slower than avg
Panel avg: 115d · This submission: 372d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 222
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K211123.
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LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing
K210718 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2022
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
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K210466 · Winner Medical Co., Ltd. · Jan 2022