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
FDA 510(k) Regulatory Record - Shenzhen Siken 3D Technology Development Co., Ltd. General & Plastic Surgery ✕
4 devices
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