LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
by HuiZhou Foryou Medical Devices Co., LTD.
510(k) K242856
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK242856 | Date13 Nov 2024 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- FRO
- Device Class
- U
- Advisory Committee
- Unknown
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Luofucon Silicone Silver-Ion Foam Dressing is a silicone foam dressing infused with silver ions (Ag+) designed to provide antibacterial protection. It falls under the category of wound care dressings, offering a barrier to prevent microbial contamination while promoting a moist wound environment to support healing.
This dressing is supplied in multiple configurations—Bordered, Bordered Lite, Non-Bordered, and Transfer—each tailored for different wound management needs. It is intended for single-use applications and is classified under FDA 510(k) clearance (K242856) with Special Substantial Equivalence determination, alongside compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). Sterility and packaging specifications are not detailed in the provided data.
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Questions
AI-generated answers, 18 Sep 2026
What types of wounds is this foam dressing designed to protect against microbial contamination, and how does the silver-ion infusion help?
The Luofucon Silicone Ag+ Foam Dressing is designed to provide antibacterial protection for wounds by incorporating silver ions (Ag+), which help inhibit microbial growth. This dressing creates a barrier against contamination while maintaining a moist wound environment, which is ideal for promoting healing in various wound types, including acute or chronic wounds where infection risk is a concern.
Are there different versions of this dressing, and what are the key differences between them?
Yes, the Luofucon Silicone Ag+ Foam Dressing comes in four configurations: Bordered, Bordered Lite, Non-Bordered, and Transfer. These variations are tailored to different clinical needs, such as wound size, location, or ease of application. For example, the Bordered and Bordered Lite versions likely offer additional support or adhesion for larger or more vulnerable wounds, while the Transfer version may be designed for easier application onto prepped wound sites.
Is this dressing meant for single-use only, and if so, what does that mean for clinical workflows?
Yes, the Luofucon Silicone Ag+ Foam Dressing is intended for single-use applications. This means each dressing should be used once and then discarded, reducing the risk of cross-contamination between patients. Clinically, this simplifies workflows by eliminating the need for reprocessing or sterilization between uses, though it may require more frequent restocking of supplies.
How is this product regulated, and what does the FDA’s Special Substantial Equivalence (SESE) determination imply about its safety and performance?
This dressing holds an FDA 510(k) clearance (K242856) with a Special Substantial Equivalence determination, meaning it has been compared to a legally marketed predicate device and found to have the same intended use, technological characteristics, and performance. The SESE designation suggests that the product’s safety and effectiveness have been evaluated against a similar, already-approved device, reinforcing its regulatory compliance and clinical reliability.