LUOFUCON® Antimicrobial Wound Gel— 510(k) K252028
Substantially EquivalentHuizhou Foryou Medical Co., Ltd.
FDA 510(k) clearance K252028 for LUOFUCON® Antimicrobial Wound Gel, Substantially Equivalent on 2026-03-11. Applicant: Huizhou Foryou Medical Co., Ltd.. Device class: Unclassified.
Summary
Huizhou Foryou Medical's LUOFUCON® Antimicrobial Wound Gel is filed under FRO, drug wound dressings. "Antimicrobial" is part of the product's name, and the record doesn't describe the gel beyond that name and code name.
The device class is listed as U, with no regulation number. The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Traditional 510(k).
Huizhou Foryou Medical filed from Huizhou, China. Review took 254 calendar days (June 30, 2025 to March 11, 2026).
Clearance details
- Applicant
- Huizhou Foryou Medical Co., Ltd.
- Product code
- Product code FRO
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huizhou, CN
Recent devices under product code FRO
view allAdverse events under product code FRO
product code FRO- Death
- 30
- Injury
- 653
- Malfunction
- 479
- Other
- 11
- Total
- 1,173
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.