Name: Predicase
Price: 199 USD

K-number	K250642
Device name	LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
Applicant	Huizhou Foryou Medical Devices Co., Ltd.
Product code	FRO
Device class	Class U
Decision date	Nov 19, 2025
Decision	Substantially Equivalent
Regulation	—

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)

Everything you need for a 510(k) submission. Nothing you don't.