Shenzhen Siken 3d Technology Development Co., Ltd.
Registered establishment in Dongguan, Guangdong, China. 6 device types, 6 clearances.
Shenzhen Siken 3D Technology Development Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Massager, Therapeutic, Electric, Lamp, Infrared, Therapeutic Heating and 4 other device types. Its earliest product listing with the FDA dates from 2009.
6device types registered with the FDA
6510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3007744197 |
| FEI number | 3007744197 |
| Establishment type | Manufacturer |
Location
| City | Dongguan |
|---|---|
| Province | Guangdong |
| Address | 6th Floor, Building E26, Tian’an Shenchuang Valley, Fenggang Town |
| Postal code | 523707 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | Class 2 | INIA BEAUTY DEVICE for Body (Model:INIA-BD101) | 2026 | 235 |
| Light Based Over The Counter Wrinkle Reduction | Class 2 | 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), Penguin™ LED Sculpt Pro(Prospera DL039 reference to SKB-2209), Multi-functional Facial Beauty Device(SKB-1703, SKB-1803, SKB-1809, SKB-1909, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209 | 2024 | 67 |
| Light Based Over-The-Counter Hair Removal | Class 2 | IPL Cooling Hair Removal Device, model: SKB-1808, SKB-2308, SKB-2128N, SKB-2188N, IPL Cooling Hair Removal Device, model: SKB-2008, SKB-2128, SKB-2188, SKB-2118 | 2022 | 69 |
| Massager, Therapeutic, Electric | Class 1 | Massager, Multiple types, Multi-functional beauty device, SKB-1909 | 2009 | 437 |
| Over-The-Counter Powered Light Based Laser For Acne | Class 2 | Penguin™ LED Sculpt Pro(Prospera DL039 reference to SKB-2209), Multi-functional Facial Beauty Device(SKB-1703, SKB-1803, SKB-1809, SKB-1909, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209 | 2026 | 59 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Class 2 | Aphrona Galvanic SPA-facial toning device; Aphrona EMS microcurrent face lift device, Nuovaluce Mini Device, Model number 213-MN, Multi-functional Facial Beauty Device(SKB-1703,SKB-1803,SKB-1909,SKB-2003,SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | 2020 | 22 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252146 | 2025-12-23 | NFO | Traditional | This company |
| K252142 | 2025-12-05 | OHS | Traditional | This company |
| K243040 | 2024-12-20 | OHS | Traditional | This company |
| K232845 | 2023-11-14 | OHT | Traditional | This company |
| K222710 | 2022-12-01 | OHT | Traditional | This company |
| K163470 | 2017-06-02 | NFO | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2000 |
|---|---|
| Main products | IPL hair removal devices, LED face masks, RF anti-aging devices, EMS body slimming massagers, Vacuum blackhead removal tools |
| Certifications | ISO 9001, ISO 13485, FDA, CE, ROHS |
| Export markets | US, Germany, Spain, Portugal, France, Italy, Poland, South Korea, Saudi Arabia |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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