Data / Medical devices / South Korea / Lutronic Corporation

Lutronic Corporation: FDA-registered device maker in Goyang-si Gyeonggi, South Korea, 6 510(k) clearances

Name: Lutronic Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Lutronic Corporation is registered with the FDA (registration 3004483538) in Goyang-si Gyeonggi, South Korea. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 23, 2017. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004483538
Address: 219, Sowon-Ro Deogyang-gu, Goyang-si Gyeonggi, South Korea, 10534
Owner or operator: Lutronic Aesthetics, Inc. (9058403)
Roles: Manufacturer
First device listed: December 12, 2007
Registered through: 2026
Brand names listed: DENTA III, DENTA III+, ECO2 PLUS, INIFINI, LaseMD, MOSAIC 3D, XERF, eCO2 3D

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument With MicrobeamFractional Output	ONG	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
June 23, 2017	K171009	LASEMD Laser System	GEX	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
June 25, 2013	K121481	INFINI RADIOFREQUENCY SYSTEM	GEI	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
January 20, 2011	K100610	LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS	ONG	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
July 13, 2007	K070392	MOSAIC LASER SYSTEM	GEX	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
April 15, 2005	K050254	SPECTRA-SP CO2 LASER SYSTEM	GEX	Substantially Equivalent	Max Engineering , Ltd.	accessdata.fda.gov
December 3, 2003	K032735	SPECTRA QT: Q-SWITCHED ND: YAG LASER SYSTEM	GEX	Substantially Equivalent	Max Engineering , Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 6, 2026	99601	Class II	Ongoing	Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system may be configured wit	Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment, potentially resulting in patient burn.	accessdata.fda.gov
January 27, 2026	98372	Class II	Ongoing	CLARITY II Laser System; Model No. 1110200210.	Reports of devices sparking/popping and potentially burning patients.	accessdata.fda.gov
September 4, 2025	97620	Class II	Ongoing	XERF EFFECTOR 60. Electrosurgical unit.	Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.	accessdata.fda.gov

Compare with other makers

Updated September 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.