LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)— 510(k) K250642

Substantially Equivalent

Huizhou Foryou Medical Devices Co., Ltd.

FDA 510(k) clearance K250642 for LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.), Substantially Equivalent on 2025-11-19. Applicant: Huizhou Foryou Medical Devices Co., Ltd..

Clearance details

Applicant: Huizhou Foryou Medical Devices Co., Ltd.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2025-03-04
Decision date: 2025-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huizhou, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.