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The Tracker / August 2026 / K254256

510(k) cleared

LUOFUCON® Wound Matrix

Huizhou Foryou Medical Devices Co., Ltd. · Aug 18, 2026 · K254256

FDA cleared the LUOFUCON® Wound Matrix from Huizhou Foryou Medical Devices Co., Ltd. on Aug 18, 2026 under K254256, a traditional 510(k). The device falls under product code QSZ, Absorbable Synthetic Wound Dressing as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 29, 2025. The decision came 232 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Huizhou Foryou Medical Devices Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K252028 (LUOFUCON® Antimicrobial Wound Gel), K250642 (LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)).

Questions & Answers

What did FDA clear under K254256?

K254256 is the FDA 510(k) for LUOFUCON® Wound Matrix, submitted by Huizhou Foryou Medical Devices Co., Ltd.. FDA's decision date was Aug 18, 2026, under product code QSZ (Absorbable Synthetic Wound Dressing).

Who makes the LUOFUCON® Wound Matrix?

Huizhou Foryou Medical Devices Co., Ltd., based in Huizhou, is the applicant of record for K254256.

How long did the K254256 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Aug 18, 2026, 232 days later.

← All decisions in August 2026

Sources