# Xuzhou Kernel Medical Equipment Co., Ltd.

- Location (FDA's records): Xuzhou, CN
- FDA decisions: 9 (2014–2026): 9 510(k) clearances
- Product codes: FTC (4), OAP (2), GEX (1), HEX (1)
- 510(k) review time since 2016: median 138 days, against 89 for FDA's reviews in the same codes and years (1 of 6 faster)
- Predicates its devices cite: 16 (2 its own); citations of its devices by later devices: 8 (2 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
- Capillus, LLC: 2 (https://510kreport.com/company/capillus)
- Freedom Laser Therapy, Inc.: 2 (https://510kreport.com/company/freedom-laser-therapy)
- Chongqing Peninsula Medical Technology Co., Ltd.: 2 (https://510kreport.com/company/chongqing-peninsula-medical-technology)
- Shanghai Apolo Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/shanghai-apolo-medical-technology)
- Raja Trading Company, Inc.: 1 (https://510kreport.com/company/raja-trading)
- Sunetics International Marketing Group, LLC: 1 (https://510kreport.com/company/sunetics-international-marketing-group)
- Dermascalp, LLC: 1 (https://510kreport.com/company/dermascalp)
- Goldway Us, Inc.: 1 (https://510kreport.com/company/goldway-us)

## Firms that cite its devices most
- Xuzhou Yongkang Electronic Science Technology Co., Ltd.: 1 (https://510kreport.com/company/xuzhou-yongkang-electronic-science-technology)
- Shanghai Omni Laser Skinology Co., Ltd.: 1 (https://510kreport.com/company/shanghai-omni-laser-skinology)
- Inwound Aps: 1 (https://510kreport.com/company/inwound)
- Yassen Wellness, LLC: 1 (https://510kreport.com/company/yassen-wellness)
- Xemis Medical Technology (Shenzhen) Co., Ltd.: 1 (https://510kreport.com/company/xemis-medical-technology-shenzhen)
- Shenzhen Honpal Optoelectronic Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-honpal-optoelectronic-technology)

## Its most-cited devices
- K222751: LED Light Therapy Device, KN-7000L (2023), cited by 4
- K181805: UV Phototherapy (2019), cited by 2
- K132643: UV Phototherapy (2014), cited by 1
- K200971: 308nm Excimer System (2020), cited by 1

## Recent decisions
- K261775: Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) (Jul 21, 2026)
- K242977: 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) (Feb 6, 2025)
- K222751: LED Light Therapy Device, KN-7000L (Feb 1, 2023)
- K200971: 308nm Excimer System (Dec 15, 2020)
- K200929: Hair Growth System (Jun 3, 2020)
- K190685: Hair Growth System (Jul 26, 2019)
- K181805: UV Phototherapy (Jan 11, 2019)
- K160341: Colposcope System (Sep 14, 2016)

Source page: https://510kreport.com/company/xuzhou-kernel-medical-equipment