FDA 510(k)

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

N.º K: K250642 · 2025-11-19

SolicitanteHuizhou Foryou Medical Devices Co., Ltd.

Fecha de decisión2025-11-19

Código de productoFRO

DecisiónSubstantially Equivalent

Resumen del dispositivo

LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2025-11-19 under 510(k) 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.

Preguntas frecuentes

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. The listed applicant is Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K250642.

When did LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) receive FDA 510(k) clearance?

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

Who is the listed applicant for LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)?

The FDA 510(k) record lists Huizhou Foryou Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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Otros registros que enlistan a Huizhou Foryou Medical Devices Co., Ltd. como solicitante

K254256LUOFUCON® Wound Matrix K240809LUOFUCON® Silver Collagen Dressing K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)K240485LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)K232796LUOFUCON® Collagen Particles (Collagen Wound Dressing)K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing

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Fuente oficial

Ver en la base de datos de la FDA →

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