LUOFUCON® Wound Matrix— 510(k) K254256
Substantially EquivalentHuizhou Foryou Medical Devices Co., Ltd.
FDA 510(k) clearance K254256 for LUOFUCON® Wound Matrix, Substantially Equivalent on 2026-08-18. Applicant: Huizhou Foryou Medical Devices Co., Ltd.. Device class: Unclassified.
Summary
Huizhou Foryou Medical Devices filed LUOFUCON Wound Matrix under product code QSZ, absorbable synthetic wound dressings. The record gives no sizes or model numbers.
The device class is listed as U, with no regulation number, and the classification panel is listed as Unknown. The General and Plastic Surgery review panel handled it as a Traditional 510(k).
Foryou filed from Huizhou, China. The substantially equivalent decision came 232 calendar days after receipt (December 29, 2025 to August 18, 2026).
Clearance details
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
- Product code
- Product code QSZ
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Huizhou, CN
Recent devices under product code QSZ
view allMore clearances from Huizhou Foryou Medical Devices Co., Ltd.
view all- K250642 — LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
- K240809 — LUOFUCON® Silver Collagen Dressing
- K242856 — LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
- K240485 — LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
- K232796 — LUOFUCON® Collagen Particles (Collagen Wound Dressing)
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