Cleared Traditional

K240809 - LUOFUCON® Silver Collagen Dressing (FDA 510(k) Clearance)

K240809 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery device

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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