Shenzhen Siken 3D Technology Development Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Shenzhen Siken 3D Technology Development Co., Ltd. - FDA 510(k) Clear...
Recent clearances: Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209), Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209), LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
6
Total
6
Cleared
0
Denied
Shenzhen Siken 3D Technology Development Co., Ltd. has 6 FDA 510(k) cleared medical devices. Based in Shenzhen, CN.
Latest FDA clearance: Dec 2025. Active since 2017. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Shenzhen Siken 3D Technology Development Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Feiying Drug & Medical Consulting Technical Service Group as regulatory consultant.
FDA 510(k) Regulatory Record - Shenzhen Siken 3D Technology Development Co., Ltd.
6 devices
Cleared
Dec 23, 2025
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003...
Neurology
167d
Cleared
Dec 05, 2025
Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909,...
General & Plastic Surgery
150d
Cleared
Dec 20, 2024
LED Light Therapy Mask...
General & Plastic Surgery
84d
Cleared
Nov 14, 2023
IPL Cooling Hair Removal Device
General & Plastic Surgery
61d
Cleared
Dec 01, 2022
IPL Cooling Hair Removal Device
General & Plastic Surgery
84d
Cleared
Jun 02, 2017
Galvanic Spa, Model: SKB-1405
Neurology
172d