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Data / Medical devices / China / Shenzhen Suyzeko Limited

Shenzhen Suyzeko Limited: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance

Shenzhen Suyzeko Limited is registered with the FDA (registration 3015522128) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 1, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3015522128
Address
Room 301, building N, no.17 innovation industrial park, xintian community guanhu street,longhua district, Shenzhen Guangdong, China, 518110
Owner or operator
Shenzhen Suyzeko Limited (10060626)
Roles
Contract manufacturer, Manufacturer
First device listed
June 4, 2019
Registered through
2026
Brand names listed
Infrared LED Heating PAD,GY-P8, GY-P8-L, GY-P8-S,GY-P60,GY-P200,GY-P264,GY-P8,GY-P8L,GY-P8S,GY-P200X,GY-264X,GY-P200T, Infrared LED Helmet,GY-PDT-8, GY-PDT-1,GY-PDT-2,GY-L21,Neuradiant 1070, Led Light Phototherapy Bed (Pro 450/ GY680A), Led Light Phototherapy Bed,Trifecta Light PRO450,PRO450/ GY-680A,GY-1280DP/GY-1280PRO, Pneumatic therapeutic shockwave ,electric massager ,GY-ESWT-P,GY-ESWT,ESWT-KP-B,Double C,Tecar, Smart Tecar,Tecar Pro, Red light chamber,GY-W4L, Red light therapy bed,GY-W4L, GY- W8,GY- W6, Ultrasound Massager,GY-CS01 ,GY-UT08,GY-UT28,GY-UT38 and more

Devices it lists

DeviceProduct codeClassRoleSource
Fat Reducing Low Level LaserOLI2Manufactureraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Contract manufacturer, Manufactureraccessdata.fda.gov
Massager, Therapeutic, ElectricISA1Contract manufacturer, Manufactureraccessdata.fda.gov
Pad, Heating, PoweredIRT2Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
December 1, 2025K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)OLISubstantially EquivalentShenzhen Suyzeko Limited.accessdata.fda.gov

Compare with other makers

Updated December 1, 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.