Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004483538

FEI Number

3004483538

Entity Name

LUTRONIC CORPORATION

City/State/Country

Goyang-si Gyeonggi, KR

Establishment Address

219, Sowon-Ro, Deogyang-gu, Goyang-si Gyeonggi 10534, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Lutronic Aesthetics, Inc. (Owner Number: 9058403)

Owner / Operator Contact Address

3/5 Carlisle Road, Westford, MA 01886, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171009

PMA Number

N/A

All Registered Proprietary Names

DENTA III+ ECO2 PLUS DENTA III INIFINI eCO2 3D XERF LaseMD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONG	Powered Laser Surgical Instrument With MicrobeamFractional Output	General, Plastic Surgery	Class 2	878.4810	2013-01-14
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2013-01-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-07-15
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2017-07-26

Official Correspondent

Sean Reynolds

US Agent Details

Sean Reynolds Business: Cynosure LLC Email: sean.reynolds@cynosurelutronic.com Phone: (978) 8429864

Related Public Records

Same Entity

Lutronic Aesthetics, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3043532708	Cynosure Lutronic Technology Corporation	Daegu Gyeongbuk, KR
3006247712	Lutronic Aesthetics, Inc.	Westford, MA, US
3033511105	Cynosure Lutronic Technology Corporation	Goyang Gyeonggi, KR
3023706404	Lutronic Corporation	Daegu Gyeongbuk, KR
3013789508	Lutronic Corporation	Goyang-si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number	Establishment Name	Location
3006247712	Lutronic Aesthetics, Inc.	Westford, MA, US
3043047259	BLINK BRIGHT MEDICAL, INC.	Houston, TX, US
3016661372	FACE ONLINE STORE LLC	New York, NY, US
3013789508	Lutronic Corporation	Goyang-si Gyeonggi, KR
3007120647	SHANGHAI APOLO MEDICAL TECHNOLOGY CO.,LTD.	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004483538. Last updated year: 2026. Please use registration number 3004483538 when referencing this establishment in official correspondence.