K250642 is an FDA 510(k) clearance for the LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.). 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 November 19, 2025, 260 days after receiving the submission on March 4, 2025.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K250642 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 2025 |
| Decision Date | November 19, 2025 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FRO — Dressing, Wound, Drug |
| Device Class | — |