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Xuzhou Kernel Medical Equipment Co Ltd: FDA-registered device maker in Xuzhou Jiangsu, China, 10 510(k) clearances

Name: Xuzhou Kernel Medical Equipment Co Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Xuzhou Kernel Medical Equipment Co Ltd is registered with the FDA (registration 3008393409) in Xuzhou Jiangsu, China. It lists 7 device types. The FDA files 10 510(k) clearances under its listings, the newest dated July 21, 2026. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3008393409
Address: Kernel Mansion Economic Development District, Xuzhou Jiangsu, China, 221004
Owner or operator: XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD (10046889)
Roles: Contract manufacturer, Manufacturer
First device listed: May 27, 2014
Registered through: 2026
Brand names listed: 308nm Excimer Phototherapy Device, 308nm Excimer System, CN-308E KN-4003B3 KN-4003B4 KN-5000C KN-5000D KN-5000H KN-5000K, Colposcope System, ExciLight, FolliLight, Hair Growth System Device (Model: KN-8000A), Hair Growth System Model: KN-8000B; KN-8000C; KN-8000D; KN-8000E, and more

Devices it lists

Device	Product code	Class	Role	Source
Colposcope (And Colpomicroscope)	HEX	2	Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Contract manufacturer	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Manufacturer	accessdata.fda.gov
Light, Ultraviolet, Dermatological	FTC	2	Manufacturer	accessdata.fda.gov
Light, Wood'S, Fluorescence	GMB	1	Manufacturer	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Contract manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 21, 2026	K261775	Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)		Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
February 6, 2025	K242977	308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K)	FTC	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
February 1, 2023	K222751	LED Light Therapy Device, KN-7000L	GEX	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
December 15, 2020	K200971	308nm Excimer System	FTC	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
June 3, 2020	K200929	Hair Growth System	OAP	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
July 26, 2019	K190685	Hair Growth System	OAP	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
January 11, 2019	K181805	UV Phototherapy	FTC	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
July 28, 2017	K170187	Photodynamic Therapy Device	GEX	Substantially Equivalent	Uvbiotek, LLC	accessdata.fda.gov
September 14, 2016	K160341	Colposcope System	HEX	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov
January 30, 2014	K132643	UV PHOTOTHERAPY	FTC	Substantially Equivalent	Xuzhou Kernel Medical Equipment Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated July 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.