FDA 510(k)

LOUFOCON®皮膚及傷口清潔劑（噴霧、霧狀、壓嘴、瓶裝。）

K 號：K250642 · 2025-11-19

申請人Huizhou Foryou Medical Devices Co., Ltd.

決定日期2025-11-19

產品代碼FRO

決定相當於

器材摘要

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.

常見問題

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.)?

FDA 510(k) 記錄將惠州富友醫療設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

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.

其他以 Huizhou Foryou Medical Devices Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254256LOUFUCON® 黃金創傷組織 K240809LOUFOCON® 銀膠原蛋白敷料 K242856LUOFUCON®矽膠Ag+泡沫敷料（處方用）/ LUOFUCON®矽膠Ag+抗菌泡沫敷料（OTC用）(邊框型、邊框輕型、無邊框型和轉移型)K240485LUOFUCON® 銀膠凝纖維敷料（處方用），LUOFUCON® 銀抗菌膠凝纖維敷料（OTC用）K232796LOUFOCON® 膠原蛋白粒子（膠原蛋白傷口敷料）K223360LOUFOCON® 硅膠Ag+ 泡沫敷料，LOUFOCON® 硅膠Ag+ 抗菌泡沫敷料

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相關器械（代碼：FRO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K254168Actolind® (06.3637. Actolind®膠漿)ACTO GmbH K254041皮膚智選抗菌濕凝膠Magic Science Supply, LLC K261646Redermax® 抗菌傷口組織Beijing Kreate Medical Co., Ltd.K253665Vashe Plus 抗菌溶液Urgo Medical North America, LLC K251929SilverCeuticals® 抗菌傷口膠Silverceuticals, Inc.K261023微達辛傷口灌洗溶液Sonoma Pharmaceuticals, Inc.

官方來源

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