FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
K Number: K252053
·
Decision Oct 27, 2025
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
152
Applicant Total
1
Review Days
118
Basic Information
- Device Name
- VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F)
- K Number
- K252053
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Touchbeauty Beauty & Health ( Shenzhen ) Co., Ltd
- Date Received
- July 1, 2025
- Decision Date
- October 27, 2025
- Product Code
- OHS
- 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 |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | FDA class 2 | General, Plastic Surgery |
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