K250642
- 510(k) number
- K250642
- Device name
- LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd. CN
- Product code
- FRO — Dressing, Wound, Drug
- Decision date
- 2025-11-19
- Date received
- 2025-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250642.pdf
Official FDA record: K250642
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.