510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254256Substantially Equivalent

LUOFUCON® Wound Matrix

Huizhou Foryou Medical Devices Co., Ltd., Huizhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K254256 is the FDA 510(k) clearance record for LUOFUCON® Wound Matrix, cleared for Huizhou Foryou Medical Devices Co., Ltd. on under FDA product code QSZ (Absorbable Synthetic Wound Dressing). FDA's definition for product code QSZ reads: "Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application". As of , FDA records show no recalls naming K254256.

Clearance record

Decision date
Received
(232 days to decision)
Product code
QSZ Absorbable Synthetic Wound Dressing
Device class
Unclassified
Review panel
Unknown
Applicant
Huizhou Foryou Medical Devices Co., Ltd. North Shangxia Rd. Dongjiang Hi-Tech Industry Park, Huizhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSZ

Trailing 12 months
3 clearances under product code QSZ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QSZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20261
October 20260