Data / Medical devices / China / Shenzhen Siken 3D Technology Development Co., Ltd.
Shenzhen Siken 3D Technology Development Co., Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 6 510(k) clearances
Shenzhen Siken 3D Technology Development Co., Ltd. is registered with the FDA (registration 3007744197) in Dongguan Guangdong, China. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 23, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007744197
- Address
- 6th Floor, Building E26, Tian'an Shenchuang Valley, Fenggang Town, Dongguan Guangdong, China, 523707
- Owner or operator
- Shenzhen Siken 3D Technology Development Co., Ltd. (10029432)
- Roles
- Manufacturer
- First device listed
- May 13, 2009
- Registered through
- 2026
- Brand names listed
- Aphrona Galvanic SPA-facial toning device; Aphrona EMS microcurrent face lift device, INIA BEAUTY DEVICE for Body (Model:INIA-BD101), 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, 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), Massager, Multiple types, Multi-functional Facial Beauty Device(SKB-1703, SKB-1803, SKB-1809, SKB-1909, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Manufacturer | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 23, 2025 | K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | NFO | Substantially Equivalent | Shenzhen Siken 3D Technology Development Co., Ltd. | accessdata.fda.gov |
| December 5, 2025 | K252142 | Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) | OHS | Substantially Equivalent | Shenzhen Siken 3D Technology Development Co., Ltd. | accessdata.fda.gov |
| December 20, 2024 | K243040 | LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) | OHS | Substantially Equivalent | Shenzhen Siken 3D Technology Development Co., Ltd. | accessdata.fda.gov |
| November 14, 2023 | K232845 | IPL Cooling Hair Removal Device | OHT | Substantially Equivalent | Shenzhen Siken 3D Technology Development Co., Ltd. | accessdata.fda.gov |
| December 1, 2022 | K222710 | IPL Cooling Hair Removal Device | OHT | Substantially Equivalent | Shenzhen Siken 3D Technology Development Co., Ltd. | accessdata.fda.gov |
| June 2, 2017 | K163470 | Galvanic Spa, Model: SKB-1405 | NFO | Substantially Equivalent | Shenzhen Siken 3D Technology Development Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Light Based Over-The-Counter Hair Removal
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
Updated December 23, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.