FDA Registration
Active
🇨🇳 China
Shenzhen Siken 3D Technology Development Co., Ltd.
Reg #: 3007744197
·
FEI: 3007744197
·
Expires 2026
Products
6
Proprietary Names
16
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Shenzhen Siken 3D Technology Development Co., Ltd.
- Registration Number
- 3007744197
- FEI Number
- 3007744197
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6th Floor, Building E26, Tian'an Shenchuang Valley, Fenggang Town
- City
- Dongguan Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222710
Owner / Operator
- Firm Name
- Shenzhen Siken 3D Technology Development Co., Ltd.
- Operator Number
- 10029432
- Address
- Room 1104, Building 2, Jiayu Environmental Protection Factory, No. 162, Shajiang Road, Xitou Community, Songgang Street, 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 |
|---|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2009-05-13 |
| Light Based Over-The-Counter Hair Removal | OHT | Class 2 | General, Plastic Surgery | No | 2022-12-04 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2026-01-06 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2026-01-06 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2026-01-06 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-01-16 |
Proprietary Names
Massager, Multiple types
Multi-functional beauty device, SKB-1909
IPL Cooling Hair Removal Device, model: SKB-2008, SKB-2128, SKB-2188, SKB-2118
IPL Cooling Hair Removal Device, model: SKB-1808, SKB-2308, SKB-2128N, SKB-2188N
Multi-functional Facial Beauty Device(SKB-1703, SKB-1803, SKB-1809, SKB-1909, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209
Penguin LED Sculpt Pro(Prospera DL039 reference to SKB-2209)
Multi-functional Facial Beauty Device(SKB-1703,SKB-1803,SKB-1909,SKB-2003,SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
LED Light Therapy Mask(Models: SKB-1818P, SKB-1918, SKB-1918P, SKB-1918PLUS)
LED Light Therapy Mask ( Models: SKB-2318L, SKB-2318P, SKB-2318PRO, IN-FM002, SKB-2418)
Nuovaluce Mini Device, Model number 213-MN
Aphrona Galvanic SPA-facial toning device; Aphrona EMS microcurrent face lift device
INIA GLOW 4D L Device for Face (Model:INIA-FM102)
INIA GLOW 4D Device for Face (Model:INIA-FM101)
INIA BEAUTY DEVICE for Body (Model:INIA-BD101)
INIA GLOW Eye Device (Model:INIA-EM101)
INIA BEAUTY DEVICE for Face (Model:INIA-BD100)
Establishment Types
Manufacture Medical Device