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Data / Medical devices / Powered Laser Surgical Instrument / South Korea

FDA-registered makers of Powered Laser Surgical Instrument in South Korea: 24 establishments

24 establishments in South Korea are registered with the FDA to make Powered Laser Surgical Instrument (product code GEX). 21 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers of this device in South KoreaWatch these makers
Device
Powered Laser Surgical Instrument
Product code
GEX
Country
South Korea

Makers of Powered Laser Surgical Instrument in South Korea

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
WONTECH Co., Ltd.Daejeon, South KoreaManufacturer24December 19, 2025000api.fda.gov
LaseroptekSeongnam Gyeonggi, South KoreaManufacturer10February 7, 2025000api.fda.gov
Classys IncAnyang-si Gyeonggi, South KoreaManufacturer8November 20, 2025000api.fda.gov
Jeisys Medical Inc.Seoul, South KoreaManufacturer8October 3, 2025000api.fda.gov
Bison Medical Co., LtdGeumcheon gu Seoul, South KoreaContract manufacturer, Manufacturer6November 2, 2018000api.fda.gov
BLUECORE COMPANY Co., Ltd.Yangsan Gyeongnam, South KoreaManufacturer5October 10, 2024000api.fda.gov
Cynosure Lutronic Technology CorporationGoyang Gyeonggi, South KoreaContract manufacturer, Manufacturer5February 4, 2022000api.fda.gov
Lutronic CorporationGoyang-si Gyeonggi, South KoreaManufacturer4June 23, 2017020api.fda.gov
Ami Inc.Geumcheon-gu Seoul, South KoreaManufacturer3June 12, 2024000api.fda.gov
Amt Engineering Co., Ltd.Seongnam-si Gyeonggi, South KoreaManufacturer3September 6, 2024000api.fda.gov
Daeju Meditech Engineering Co., Ltd.Seoul, South KoreaManufacturer3March 7, 2025000api.fda.gov
Ids LtdGeumcheon-gu Seoul, South KoreaManufacturer3December 21, 2023000api.fda.gov
Speclipse, Inc.Ansan-si Gyeonggi, South KoreaComplaint file establishment, Manufacturer3May 11, 2026000api.fda.gov
FINEMEC Co., LtdGangseo-gu Seoul, South KoreaExporter to the US, Manufacturer2November 30, 2018000api.fda.gov
SNJ Co LtdGuro-Gu Seoul, South KoreaManufacturer2April 12, 2022000api.fda.gov
Elemenic Co., Ltd.Seoul, South KoreaManufacturer1March 15, 2018000api.fda.gov
Hironic Co., Ltd.Yongin-Si Gyeonggi, South KoreaManufacturer1October 19, 2021000api.fda.gov
Hulaser, Inc.GEUMCHEON-GU Seoul, South KoreaManufacturer1November 19, 2020000api.fda.gov
Lameditech Co., Ltd.Seoul, South KoreaManufacturer1March 7, 2018000api.fda.gov
Ltra Global Co. Ltd.Seongnam Gyeonggi, South KoreaManufacturer1January 22, 2021000api.fda.gov
Medmix Co.,ltdYeonsu-gu Incheon, South KoreaManufacturer1July 12, 2022000api.fda.gov
Ids LtdPaju Gyeonggi, South KoreaManufacturer0000api.fda.gov
Nson Co., Ltd.Anyang Gyeonggi, South KoreaContract manufacturer0000api.fda.gov
SRMC Co., Ltd.Cheongju-si Chungbuk, South KoreaManufacturer0000api.fda.gov

Updated November 2, 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.