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Lutronic Corporation

Korea, Republic · Goyang-Si

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

4listed device types

Class I 0Class II 4Class III 0

plus 22 registration records and 29 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

7 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

8active device licences

Class III 8

12 including historic records

TWTaiwanTFDA

21valid device licences

Class II 21

SGSingaporeHSA SMDR

9device registrations

CLASS B 1CLASS C 8

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

13active ARTG entries

IIa 1IIb 12

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

16active registrations

Class 2a 1Class 2b 15

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States22 registration records, 29 510(k), 0 PMA, 6 excluded

Brazil1 confirmed, 1 excluded

Canada8 confirmed, 1 excluded

Manufacturer names merged into this page: Lutronic Corporation · LUTRONIC CORPORATION

FDA 510(k) clearances by year

22007

42008

22009

12010

22011

42012

22013

12014

12016

22017

22018

12019

12021

22022

22025

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Lamp, Infrared, Therapeutic Heating 1Powered Laser Surgical Instrument 1Powered Laser Surgical Instrument With MicrobeamFractional Output 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251327	XERF	2025-08-11
US	K244060	eCO2 3D	2025-07-31
US	K213748	CoreLevee	2022-10-14
BR	10343659007	Lutronic Genius	Class II
CA	77409	MOSAIC LASERS	Class III
CA	78136	SPECTRA VRM II DUAL PULSED Q-SWITCHED ND:YAG LASER	Class III
CA	81116	ECO2 LASER SYSTEM	Class III

Lutronic Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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