K240485 is an FDA 510(k) clearance for the LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use). This device is classified as a Dressing, Wound, Drug.
Submitted by Huizhou Foryou Medical Devices Co., Ltd. (Huizhou, CN). The FDA issued a Cleared decision on October 7, 2024, 230 days after receiving the submission on February 20, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K240485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2024 |
| Decision Date | October 07, 2024 |
| Days to Decision | 230 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |