Cleared Traditional

K211123 - LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel
(FDA 510(k) Clearance)

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

K211123 is an FDA 510(k) clearance for the LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel, a Dressing, Wound, Drug, submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on April 22, 2022, 372 days after receiving the submission on April 15, 2021. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K211123 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

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