LUOFUCON® Wound Matrix
FDA 510(k) K254256 · Huizhou Foryou Medical Devices Co., Ltd.
510(k) numberK254256
Submission
- Device name
- LUOFUCON® Wound Matrix
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
Huizhou, CN - Received
- December 29, 2025
- Decision date
- August 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QSZ – Absorbable Synthetic Wound Dressing
- Device class
- Unclassified
Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Other 510(k)s with product code QSZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261311 | HyalomatrixQSZ · Traditional | Anika Therapeutics, Inc. | 09/02/2026SE |
| K260020 | Redermo Wound MatrixQSZ · Traditional | Beijing Kreate Medical Co., Ltd. | 04/16/2026SE |
| K251567 | NovoSorb BTMQSZ · Special | Polynovo Biomaterials Pty, Ltd. | 06/20/2025SE |
| K242149 | NovoSorb® MTXQSZ · Traditional | Polynovo Biomaterials Pty, Ltd. | 03/05/2025SE |
| K241660 | SiOxD® Wound MatrixQSZ · Special | Sioxmed, LLC | 07/05/2024SE |
| K232847 | SiOxD Wound MatrixQSZ · Traditional | Sioxmed, LLC | 12/18/2023SE |
| K223725 | Restrata® MiniMatrixQSZ · Traditional | Acera Surgical, Inc. | 05/18/2023SE |
| K222189 | SiOxD Wound MatrixQSZ · Traditional | Sioxmed, LLC | 11/18/2022SE |
| K221686 | NovoSorb MatrixQSZ · Special | Polynovo Biomaterials Pty, Ltd. | 09/15/2022SE |
| K193583 | Restrata®QSZ · Special | Acera Surgical, Inc. | 09/25/2020SE |
More from Acera Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)FRO · Traditional | 11/19/2025SE |
| K240809 | LUOFUCON® Silver Collagen DressingFRO · Traditional | 12/16/2024SE |
| K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…FRO · Special | 11/13/2024SE |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver…FRO · Traditional | 10/07/2024SE |
| K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing)KGN · Traditional | 04/25/2024SE |
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingFRO · Traditional | 03/27/2024SE |
| K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber…FRO · Traditional | 01/04/2024SE |
| K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingFRO · Traditional | 12/21/2023SE |
| K213598 | LUOFUCON Collagen Wound DressingKGN · Traditional | 09/20/2022SE |
| K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelFRO · Traditional | 04/22/2022SE |
Questions and answers
When was LUOFUCON® Wound Matrix cleared by the FDA?
LUOFUCON® Wound Matrix (K254256) received a 510(k) decision of Substantially Equivalent on August 18, 2026, 232 days after the submission was received.
What is the product code of K254256?
The FDA product code is QSZ – Absorbable Synthetic Wound Dressing, a Unclassified device.