FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
K Number: K252146
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
77
Applicant Total
6
Review Days
167
Basic Information
- Device Name
- Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
- K Number
- K252146
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Shenzhen Siken 3D Technology Development Co., Ltd.
- Date Received
- July 9, 2025
- Decision Date
- December 23, 2025
- Product Code
- NFO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | FDA class 2 | Neurology |
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Other Clearances by Shenzhen Siken 3D Technology Development Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252142 | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | Dec 5, 2025 | Substantially Equivalent |
| K243040 | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) | Dec 20, 2024 | Substantially Equivalent |
| K232845 | IPL Cooling Hair Removal Device | Nov 14, 2023 | Substantially Equivalent |
| K222710 | IPL Cooling Hair Removal Device | Dec 1, 2022 | Substantially Equivalent |
| K163470 | Galvanic Spa, Model: SKB-1405 | Jun 2, 2017 | Substantially Equivalent |