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Data / Medical devices / Hong Kong / Duplex International Trading Limited

Duplex International Trading Limited: FDA-registered device maker in Hong Kong, Hong Kong, 6 510(k) clearances

Duplex International Trading Limited is registered with the FDA (registration 3010360273) in Hong Kong, Hong Kong. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 4, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3010360273
Address
B1, 10/F, Block 2, Golden Dragon Ind Centre, Tai Lin Pai Road, Kwai Chung, NT, Hong Kong, Hong Kong, 85203
Owner or operator
Duplex International Trading Limited (10084827)
Roles
Exporter to the US, Manufacturer
First device listed
April 5, 2022
Registered through
2026
Brand names listed
Facemart LED GLOW MASK (Model: KLN58A_3), LED Light Therapy Masks (PE748, PE749, PE756), LumaGlow Blue LED Light Therapy, LumaGlow Red LED Light Therapy, Project E Beauty Derma Roller, Project E Beauty LED Light Therapy Mask, Project E Beauty LED Light Therapy Mask, PE730, Project E Beauty Luma Blue and more

Devices it lists

DeviceProduct codeClassRoleSource
Brush, Dermabrasion, ManualGED1Exporter to the US, Manufactureraccessdata.fda.gov
Brush, Dermabrasion, PoweredGFE1Exporter to the US, Manufactureraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Exporter to the USaccessdata.fda.gov
Light Based Over The Counter Wrinkle ReductionOHS2Exporter to the US, Manufactureraccessdata.fda.gov
Light Based Over-The-Counter Hair RemovalOHT2Exporter to the US, Manufactureraccessdata.fda.gov
Over-The-Counter Powered Light Based Laser For AcneOLP2Exporter to the US, Manufactureraccessdata.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
August 4, 2026K261496LED Light Therapy Masks (PE748, PE749, PE756)OHSSubstantially EquivalentDuplex International Trading Limitedaccessdata.fda.gov
March 23, 2022K214101Project E Beauty LED Light Therapy Mask (Model: PE730)OHSSubstantially EquivalentDuplex International Trading Limitedaccessdata.fda.gov
July 14, 2021K202390Aduro Light Beauty MaskOHSSubstantially EquivalentShenzhen Kaiyan Medical CO , Ltd.accessdata.fda.gov
March 23, 2017K161428PerfectSmoothOHTSubstantially EquivalentShen Zhen Cosbeauty Co., Ltd.accessdata.fda.gov
January 30, 2017K162098LED Phototherapy DeviceOLPSubstantially EquivalentLi-Tek Electronic Technology Corporationaccessdata.fda.gov
December 30, 2015K152889SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUSOLPSubstantially EquivalentBiorenew Labs, LLCaccessdata.fda.gov

Compare with other makers

Updated August 4, 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.