# Shenzhen Kaiyan Medical Equipment Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 24 (2023–2026): 24 510(k) clearances
- Product codes: OHS (15), OAP (5), OLI (2), OLP (1), NFO (1)
- 510(k) review time since 2016: median 89 days, against 89 for FDA's reviews in the same codes and years (9 of 23 faster)
- Predicates its devices cite: 63 (6 its own); citations of its devices by later devices: 21 (6 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
- Light Tree Ventures Europe B.V.: 11 (https://510kreport.com/company/light-tree-ventures-europe)
- Biophotas, Inc.: 5 (https://510kreport.com/company/biophotas)
- Shenzhen Nuon Medical Equipment Co., Ltd.: 3 (https://510kreport.com/company/shenzhen-nuon-medical-equipment)
- Freedom Laser Therapy, Inc.: 2 (https://510kreport.com/company/freedom-laser-therapy)
- Kam Yuen Plastic Products, Ltd.: 2 (https://510kreport.com/company/kam-yuen-plastic-products)
- Heat IN A Click, LLC: 2 (https://510kreport.com/company/heat-in-a-click)
- iSMART Developments, Ltd.: 2 (https://510kreport.com/company/ismart-developments)
- Dongguan Laiguang Electronic Technology Co., Ltd.: 2 (https://510kreport.com/company/dongguan-laiguang-electronic-technology)

## Firms that cite its devices most
- Shenzhen Nuon Medical Equipment Co., Ltd.: 3 (https://510kreport.com/company/shenzhen-nuon-medical-equipment)
- Shenzhen Ulike Smart Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-ulike-smart-electronics)
- The Beauty Tech Group, Ltd.: 2 (https://510kreport.com/company/beauty-tech-group)
- Shenzhen Fittop Health Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-fittop-health-technology)
- Guangdong Ace-Tec Co., Ltd.: 1 (https://510kreport.com/company/guangdong-ace-tec)
- Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-xinlong-precision-plastic-mold-products)
- Zdeer Technology (Henan) Co., Ltd.: 1 (https://510kreport.com/company/zdeer-technology-henan)
- Shenzhen Chuanghong Zhilian Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-chuanghong-zhilian-technology)

## Its most-cited devices
- K240089: Face Patches (MT-12MA, MT-12MC) (2024), cited by 6
- K242363: HIGHERDOSE Red Light Hat (HG-120K) (2024), cited by 3
- K242593: CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) (2025), cited by 3
- K231321: Nooance Led And Laser Helmet (2023), cited by 1
- K233556: LED Eye mask (EY-20R, A20, EY-20N) (2024), cited by 1
- K253669: Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300) (2026), cited by 1

## Recent decisions
- K253932: FACEGYM Pro Device (HD-109) (Jul 23, 2026)
- K254025: LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) (Jun 16, 2026)
- K260688: Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) (May 4, 2026)
- K260129: Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) (Apr 15, 2026)
- K253878: LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) (Mar 4, 2026)
- K252603: HIGHERDOSE Body Sculptor (Model: GS-03) (Jan 28, 2026)
- K253669: Trudermal Halo Hair Growth System (M-180A); Aduro Hair Growth (M-130,M-300) (Jan 23, 2026)
- K252414: Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) (Oct 30, 2025)

Source page: https://510kreport.com/company/shenzhen-kaiyan-medical-equipment