Cleared Traditional

LUOFUCON? Antimicrobial Wound Gel

K252028 · Huizhou Foryou Medical Co., Ltd. · General & Plastic Surgery

Mar 2026

Decision

254d

Days

—

Risk

About This 510(k) Submission

K252028 is an FDA 510(k) clearance for the LUOFUCON? Antimicrobial Wound Gel, a Dressing, Wound, Drug, submitted by Huizhou Foryou Medical Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on March 11, 2026, 254 days after receiving the submission on June 30, 2025. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K252028 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2025
Decision Date	March 11, 2026
Days to Decision	254 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF