FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
NeoSculpt Plus
K Number: K252888
·
Decision Mar 9, 2026
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
77
Applicant Total
1
Review Days
180
Basic Information
- Device Name
- NeoSculpt Plus
- K Number
- K252888
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S&M Medical Co., Ltd.
- Date Received
- September 10, 2025
- Decision Date
- March 9, 2026
- Product Code
- PBX
- 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 |
|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | FDA class 2 | General, Plastic Surgery |
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