FDA 510(k)

LUOFUCON® Antimicrobial Wound Gel

Numéro K : K252028 · 2026-03-11

DemandeurHuizhou Foryou Medical Co., Ltd.

Date de décision2026-03-11

Code produitFRO

DécisionSubstantially Equivalent

Résumé du dispositif

LUOFUCON® Antimicrobial Wound Gel is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Foryou Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-03-11 under 510(k) number K252028. 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.

Questions fréquentes

What is the LUOFUCON® Antimicrobial Wound Gel?

LUOFUCON® Antimicrobial Wound Gel is a medical device that received FDA 510(k) clearance on 2026-03-11. The listed applicant is Huizhou Foryou Medical Co., Ltd.. The 510(k) number is K252028.

When did LUOFUCON® Antimicrobial Wound Gel receive FDA 510(k) clearance?

LUOFUCON® Antimicrobial Wound Gel received FDA 510(k) clearance on 2026-03-11, under 510(k) number K252028.

Who is the listed applicant for LUOFUCON® Antimicrobial Wound Gel?

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

What is the FDA product code for LUOFUCON® Antimicrobial Wound Gel?

The FDA product code for LUOFUCON® Antimicrobial Wound Gel is FRO. This falls under the Anesthesiology category.

Essais cliniques associés

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Dispositifs connexes (Code : FRO)

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Source officielle

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