Cleared Traditional

K240485 - LUOFUCON Extra Silver Gelling Fiber Dre...

K240485 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device
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Oct 2024
Decision
230d
Days
-
Risk

K240485 is an FDA 510(k) clearance for the LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCO.... 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 October 7, 2024 after a review of 230 days - an extended review cycle.

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. Standard predicate reliance. 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 K240485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2024
Decision Date October 07, 2024
Days to Decision 230 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
115d slower than avg
Panel avg: 115d · This submission: 230d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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