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FDA 510(k)

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

K-Number: K250642 · 2025-11-19

ApplicantHuizhou Foryou Medical Devices Co., Ltd.
Decision Date2025-11-19
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) is a medical device manufactured by Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2025-11-19 under approval number K250642. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)?

LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) is a medical device that received FDA 510(k) clearance on 2025-11-19. It is manufactured by Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K250642.

When was LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) approved by the FDA?

LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) received FDA 510(k) clearance on 2025-11-19, under approval number K250642.

What company makes LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)?

LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) is manufactured by Huizhou Foryou Medical Devices Co., Ltd..

What is the FDA product code for LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)?

The FDA product code for LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

NCT04996173 Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis) ACTIVE_NOT_RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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