Data / Medical devices / China / Dongguan Yanxi Technology Co. Ltd.

Dongguan Yanxi Technology Co. Ltd.: FDA-registered device maker in Dongguan Guangdong, China, 1 510(k) clearance

Name: Dongguan Yanxi Technology Co. Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dongguan Yanxi Technology Co. Ltd. is registered with the FDA (registration 3017618922) in Dongguan Guangdong, China. It lists 13 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 12, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017618922
Address: Room 501, Zhigu Science and Technology Park, Tianxin Village, 19 Guanglong Road, Huangjiang Town, Dongguan Guangdong, China, 523857
Owner or operator: Dongguan Yanxi Technology Co. LTD. (10086613)
Roles: Contract manufacturer, Manufacturer
First device listed: November 23, 2022
Registered through: 2026
Brand names listed: 4D Spectrum Mask Maker 2457, Spectral Therapy Mask 2525, Back Massager (YY2609), Cervical Massage Pillow (2608), Blackhead remover, Beauty inducer, Cosmetic oxygen injector, Cervical massage pillow 2442, Convertta Depuffing Wand F688, Ear cleaner 2456, Electric Ear Cleaner 2415, Electric eyebrow trimmer, Nano spray and more

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Grooming	ILW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Brush, Dermabrasion, Powered	GFE	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Humidifier, Non-Direct Patient Interface (Home-Use)	KFZ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Light Based Over The Counter Wrinkle Reduction	OHS	2	Manufacturer	accessdata.fda.gov
Mask, Scavenging	KHA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Manual	LYG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Over-The-Counter Powered Light Based Laser For Acne	OLP	2	Manufacturer	accessdata.fda.gov
Pack, Heat, Moist	IMA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Pad, Heating, Powered	IRT	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
Toothbrush, Powered	JEQ	1	Contract manufacturer, 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
September 12, 2025	K252189	LED Light Therapy Mask (2311, 2344, 2457, 2458)	OHS	Substantially Equivalent	Dongguan Yanxi Technology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 12, 2025. 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.