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Data / Medical devices / South Korea / Lutronic Corporation

Lutronic Corporation: FDA-registered device maker in Goyang-si Gyeonggi, South Korea, 13 510(k) clearances

Lutronic Corporation is registered with the FDA (registration 3013789508) in Goyang-si Gyeonggi, South Korea. It lists 4 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 11, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Lutronic Corporation
FDA registration number
3013789508
Address
Poskom Tower, 3F, 227, Sowon-ro Deogyang-gu, Goyang-si Gyeonggi, South Korea, 10534
Owner or operator
Lutronic Aesthetics, Inc. (9058403)
Roles
Exporter to the US
First device listed
January 14, 2013
Registered through
2026
Brand names listed
CLARITY II Laser System, DENTA III, DENTA III+, DermaV Laser System, ECO2 PLUS, HEALITE II, HOLLYWOOD SPECTRA, INIFINI and more

Devices it lists

DeviceProduct codeClassRoleSource
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Exporter to the USaccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Exporter to the USaccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Exporter to the USaccessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional OutputONG2Exporter to the USaccessdata.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 11, 2025K251327XERFGEISubstantially EquivalentLutronic Corporationaccessdata.fda.gov
July 31, 2025K244060eCO2 3DONGSubstantially EquivalentLutronic Corporationaccessdata.fda.gov
January 2, 2024K233550MOSAIC 3D (Surgical Laser)ONGSubstantially EquivalentLutronic Aestheticaccessdata.fda.gov
February 4, 2022K213569HOLLYWOOD SPECTRA Laser SystemGEXSubstantially EquivalentLutronic Corporationaccessdata.fda.gov
March 26, 2021K203788DermaV Laser SystemGEXSubstantially EquivalentLutronic Corporationaccessdata.fda.gov
November 12, 2019K192331LaseMD LEO Laser SystemGEXSubstantially EquivalentLutronic Globalaccessdata.fda.gov
June 14, 2019K183566CLARITY II Laser SystemGEXSubstantially EquivalentLutronic Corporationaccessdata.fda.gov
December 10, 2018K180945LUTRONIC GENIUS Radiofrequency SystemGEISubstantially EquivalentLutronic Corporationaccessdata.fda.gov
June 19, 2018K173700PICOPLUS Laser SystemGEXSubstantially EquivalentLutronic Corporationaccessdata.fda.gov
June 23, 2017K171009LASEMD Laser SystemGEXSubstantially EquivalentLutronic Corporationaccessdata.fda.gov
June 25, 2013K121481INFINI RADIOFREQUENCY SYSTEMGEISubstantially EquivalentLutronic Corporationaccessdata.fda.gov
June 19, 2012K113668HEALITE II SYSTEMILYSubstantially EquivalentLutronic Corporationaccessdata.fda.gov
January 20, 2011K100610LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMSONGSubstantially EquivalentLutronic Corporationaccessdata.fda.gov

Compare with other makers

Updated August 11, 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.