FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇳 China
LUOFUCON® Antimicrobial Wound Gel
K Number: K252028
·
Decision Mar 11, 2026
Classifications
1
FEI Numbers
384
Registration Numbers
385
Same Product Code
702
Applicant Total
1
Review Days
254
Basic Information
- Device Name
- LUOFUCON® Antimicrobial Wound Gel
- K Number
- K252028
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Huizhou Foryou Medical Co., Ltd.
- Date Received
- June 30, 2025
- Decision Date
- March 11, 2026
- Product Code
- FRO
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | FDA unclassified | Unknown |
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