Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023706404

FEI Number

3023706404

Entity Name

Lutronic Corporation

City/State/Country

Daegu Gyeongbuk, KR

Establishment Address

56 Cheombok-ro, Dong-gu, Daegu Gyeongbuk 41069, 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

K121481

PMA Number

N/A

All Registered Proprietary Names

HEALITE II INIFINI

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2013-01-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-07-15

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
3013789508	Lutronic Corporation	Goyang-si Gyeonggi, KR
3004483538	LUTRONIC CORPORATION	Goyang-si Gyeonggi, KR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
3016214547	RED DOT LED LIGHTING LIMITED	Shenzhen Guangdong, CN
3014296246	PHOTON THERAPY SYSTEMS (PTY) LTD	Pretoria Gauteng, ZA
3033920804	CHONGQING YUYI TECHNOLOGY., CO., LTD.	Chongqing, CN
3015466811	REV-MED INC.	Yongin-si Gyeonggi, KR
3035879449	DONGGUAN JIAYU ELECTRICAL CO.,LTD	Dongguan Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023706404. Last updated year: 2026. Please use registration number 3023706404 when referencing this establishment in official correspondence.