Cleared Traditional

K210718 - LUOFUCON Extra Silver Gelling Fiber Dre...

K210718 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device
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Mar 2022
Decision
378d
Days
-
Risk

K210718 is an FDA 510(k) clearance for the LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial G.... 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 March 23, 2022 after a review of 378 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 K210718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2021
Decision Date March 23, 2022
Days to Decision 378 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
263d slower than avg
Panel avg: 115d · This submission: 378d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 211
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K210718.
MEBO Wound Dressing
K222657 · Mebo Life Science, Inc. · Oct 2022
Bonvadis Topical Cream
K212554 · Stemcyte, Inc. · Aug 2022
LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
K211123 · Huizhou Foryou Medical Devices Co., Ltd. · Apr 2022
PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing
K210135 · 3M Healthcare Business Group · Feb 2022
Silver Gelling Fiber Dressing
K210466 · Winner Medical Co., Ltd. · Jan 2022
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
K202982 · Winner Medical Co., Ltd. · Oct 2021