FDA Registration
Active
🇨🇳 China
LED Light Therapy Mask ( Models: SKB-2318L, SKB-2318P, SKB-2318PRO, IN-FM002, SKB-2418)
Reg #: 3007744197
·
FEI: 3007744197
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shenzhen Siken 3D Technology Development Co., Ltd.
- Registration Number
- 3007744197
- FEI Number
- 3007744197
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Fourth building NO.33 Left East Avenue, Songgang,Bao An District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K243040
Owner / Operator
- Firm Name
- Shenzhen Siken 3D Technology Development Co., Ltd.
- Operator Number
- 10029432
- Address
- Fourth building NO.33 Left East Avenue, Songgang,Bao`an District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518105
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2024-12-22 |
Proprietary Names
LED Light Therapy Mask ( Models: SKB-2318L, SKB-2318P, SKB-2318PRO, IN-FM002, SKB-2418)
LED Light Therapy Mask(Models: SKB-1818P, SKB-1918, SKB-1918P, SKB-1918PLUS)
Establishment Types
Manufacture Medical Device