Cleared Traditional

K240809 - LUOFUCON Silver Collagen Dressing

K240809 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2024
Decision
266d
Days
-
Risk

K240809 is an FDA 510(k) clearance for the LUOFUCON® Silver Collagen Dressing. 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 December 16, 2024 after a review of 266 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 K240809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2024
Decision Date December 16, 2024
Days to Decision 266 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
151d slower than avg
Panel avg: 115d · This submission: 266d
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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