LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
FDA 510(k) K172554 · Huizhou Foryou Medical Devices Co., Ltd.
510(k) numberK172554
Submission
- Device name
- LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
Huizhou, CN - Received
- August 24, 2017
- Decision date
- May 1, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRO – Dressing, Wound, Drug
- Device class
- Unclassified
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| K254041 | SkinSmart Antimicrobial HydroGelFRO · Traditional | Magic Science Supply, LLC | 09/11/2026SE |
| K261646 | Redermax® Antibacterial Wound MatrixFRO · Traditional | Beijing Kreate Medical Co., Ltd. | 08/14/2026SE |
| K253665 | Vashe Plus Antimicrobial SolutionFRO · Traditional | Urgo Medical North America, LLC | 08/11/2026SE |
| K261023 | Microdacyn Wound Irrigation SolutionFRO · Traditional | Sonoma Pharmaceuticals, Inc. | 06/24/2026SE |
| K251929 | SilverCeuticals® Antimicrobial Wound GelFRO · Traditional | Silverceuticals, Inc. | 06/24/2026SE |
| K261638 | Bonvadis®FRO · Special | Oneness Biotech Co., Ltd. | 06/17/2026SE |
| K254073 | StatSeal DiscFRO · Traditional | Merit Medical Systems, Inc. | 05/13/2026SE |
| K254191 | IWD-GelFRO · Traditional | InnovaCorium, Inc. | 04/07/2026SE |
| K252023 | MiraChlor Antimicrobial Wound SolutionFRO · Traditional | Letus Corporation | 03/25/2026SE |
| K251999 | Promogran Prisma Collagen Matrix with ORC and SilverFRO · Traditional | Solventum Germany GmbH | 03/13/2026SE |
More from Solventum Germany GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K254256 | LUOFUCON® Wound MatrixQSZ · Traditional | 08/18/2026SE |
| 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 |
Questions and answers
When was LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing cleared by the FDA?
LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing (K172554) received a 510(k) decision of Substantially Equivalent on May 1, 2018, 250 days after the submission was received.
What is the product code of K172554?
The FDA product code is FRO – Dressing, Wound, Drug, a Unclassified device.