# Shenzhen Siken 3D Technology Development Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 6 (2017–2025): 6 510(k) clearances
- Product codes: OHS (2), OHT (2), NFO (2)
- 510(k) review time since 2016: median 117 days, against 88 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 10 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Shenzhen Aozemei Technology Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-aozemei-technology)
- Galactic Beauty, LLC: 1 (https://510kreport.com/company/galactic-beauty)
- Shenzhen Bsx Technology Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-bsx-technology-electronics)
- Xtreem Pulse, LLC: 1 (https://510kreport.com/company/xtreem-pulse)
- Belega, Inc.: 1 (https://510kreport.com/company/belega)
- Hunan Guangye Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/hunan-guangye-biotechnology)
- Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-sungpo-hi-tech-electronic)
- Carol Cole Company: 1 (https://510kreport.com/company/carol-cole)

## Firms that cite its devices most
- Dongguan Yanxi Technology Co., Ltd.: 1 (https://510kreport.com/company/dongguan-yanxi-technology)
- Shenzhen Kaiyan Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-kaiyan-medical-equipment)
- Guangdong Newdermo Biotech Co., Ltd.: 1 (https://510kreport.com/company/guangdong-newdermo-biotech)

## Its most-cited devices
- K252146: Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (2025), cited by 1
- K243040: LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) (2024), cited by 1
- K163470: Galvanic Spa, Model: SKB-1405 (2017), cited by 1

## Recent decisions
- K252146: Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (Dec 23, 2025)
- K252142: Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) (Dec 5, 2025)
- K243040: LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) (Dec 20, 2024)
- K232845: IPL Cooling Hair Removal Device (Nov 14, 2023)
- K222710: IPL Cooling Hair Removal Device (Dec 1, 2022)
- K163470: Galvanic Spa, Model: SKB-1405 (Jun 2, 2017)

Source page: https://510kreport.com/company/shenzhen-siken-3d-technology-development