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FDA 510(k)

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel

K-Number: K211123 · 2022-04-22

ApplicantHuizhou Foryou Medical Devices Co., Ltd.
Decision Date2022-04-22
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel is a medical device manufactured by Huizhou Foryou Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-04-22 under approval number K211123. 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 Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel?

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel is a medical device that received FDA 510(k) clearance on 2022-04-22. It is manufactured by Huizhou Foryou Medical Devices Co., Ltd.. The 510(k) number is K211123.

When was LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel approved by the FDA?

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel received FDA 510(k) clearance on 2022-04-22, under approval number K211123.

What company makes LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel?

LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel is manufactured by Huizhou Foryou Medical Devices Co., Ltd..

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

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

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Related PubMed Literature

PMID: 41516911 Substance-Based Medical Device in Wound Care: Bridging Regulatory Clarity and Therapeutic Innovation. Polymers (2025)

Other Devices by Huizhou Foryou Medical Devices Co., Ltd.

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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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