FDA 510(k)

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

Número K: K250642 · 2025-11-19

RequerenteHuizhou Foryou Medical Devices Co., Ltd.

Data da decisão2025-11-19

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Outros registros que listam Huizhou Foryou Medical Devices Co., Ltd. como candidato(a)

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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Fonte oficial

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