Data / Medical devices / South Korea / Cynosure Lutronic Technology Corporation

Cynosure Lutronic Technology Corporation: FDA-registered device maker in Goyang Gyeonggi, South Korea, 11 510(k) clearances

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

Cynosure Lutronic Technology Corporation is registered with the FDA (registration 3033511105) in Goyang Gyeonggi, South Korea. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated June 29, 2026. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3033511105
Address: 55 Samwon-Ro Deogyang, Goyang Gyeonggi, South Korea, 10550
Owner or operator: Lutronic Aesthetics, Inc. (9058403)
Roles: Contract manufacturer, Manufacturer
First device listed: January 14, 2013
Registered through: 2026
Brand names listed: CLARITY II Laser System, DermaV Laser System, HEALITE II, HOLLYWOOD SPECTRA, LUTRONIC GENIUS, LaseMD Ultra, MOSAIC 3D, PICOPLUS Laser System and more

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Contract manufacturer, 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 29, 2026	K253484	LUTRONIC GENIUS	GEI	Substantially Equivalent	Cynosure Lutronic Technology Corporation	accessdata.fda.gov
August 11, 2025	K251327	XERF	GEI	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
July 31, 2025	K244060	eCO2 3D	ONG	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
January 2, 2024	K233550	MOSAIC 3D (Surgical Laser)	ONG	Substantially Equivalent	Lutronic Aesthetic	accessdata.fda.gov
February 4, 2022	K213569	HOLLYWOOD SPECTRA Laser System	GEX	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
March 26, 2021	K203788	DermaV Laser System	GEX	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
November 12, 2019	K192331	LaseMD LEO Laser System	GEX	Substantially Equivalent	Lutronic Global	accessdata.fda.gov
June 14, 2019	K183566	CLARITY II Laser System	GEX	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
December 10, 2018	K180945	LUTRONIC GENIUS Radiofrequency System	GEI	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
June 19, 2018	K173700	PICOPLUS Laser System	GEX	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov
June 19, 2012	K113668	HEALITE II SYSTEM	ILY	Substantially Equivalent	Lutronic Corporation	accessdata.fda.gov

Compare with other makers

Updated June 29, 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.