FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
Automatic Micro Needle System (CODE-X)
K Number: K252591
·
Decision May 13, 2026
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
25
Applicant Total
1
Review Days
271
Basic Information
- Device Name
- Automatic Micro Needle System (CODE-X)
- K Number
- K252591
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4430
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Woorhi Mechatronics Co., Ltd.
- Date Received
- August 15, 2025
- Decision Date
- May 13, 2026
- Product Code
- QAI
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| QAI | Powered Microneedle Device | FDA class 2 | General, Plastic Surgery |
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