Cleared Special

LUOFUCON? Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON? Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)

K242856 · Huizhou Foryou Medical Devices Co., Ltd. · General & Plastic Surgery

Nov 2024

Decision

54d

Days

—

Risk

About This 510(k) Submission

K242856 is an FDA 510(k) clearance for the LUOFUCON? Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON? Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer), a Dressing, Wound, Drug, submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on November 13, 2024, 54 days after receiving the submission on September 20, 2024. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K242856 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 20, 2024
Decision Date	November 13, 2024
Days to Decision	54 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF