K211123 is an FDA 510(k) clearance for the LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel. 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 April 22, 2022, 372 days after receiving the submission on April 15, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K211123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |