Data / Medical devices / South Korea / Laseroptek

Laseroptek: FDA-registered device maker in Seongnam Gyeonggi, South Korea, 10 510(k) clearances

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

Laseroptek is registered with the FDA (registration 3007181527) in Seongnam Gyeonggi, South Korea. It lists 1 device type. The FDA files 10 510(k) clearances under its listings, the newest dated February 7, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007181527
Address: Hyundai I valley 114,116,117,203,204 and 215 31, Galmachi-ro 244beon-gil, Jungwon-gu, Seongnam Gyeonggi, South Korea, 13212
Owner or operator: Laseroptek Co., Ltd. (10029810)
Roles: Manufacturer
First device listed: June 18, 2014
Registered through: 2026
Brand names listed: HELIOS 785 Pico, HELIOS IV 785, HYPERION Long Pulsed Nd:YAG Dermatological Laser, Helios III Q-Switched Nd:YAG Laser System, Lotus III Multi-Pulsed Er: YAG Laser System, PALLAS 308/311 Solid-State UV Laser System, PALLAS Premium, PicoLO Nd:YAG Picosecond Laser System and more

Devices it lists

Device	Product code	Class	Role	Source
Powered Laser Surgical Instrument	GEX	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
February 7, 2025	K243780	HELIOS 785 Pico (1754V2)	GEX	Substantially Equivalent	Laseroptek Co., Ltd.	accessdata.fda.gov
May 22, 2023	K230373	HELIOS 785 Pico	GEX	Substantially Equivalent	Laseroptek Co., Ltd.	accessdata.fda.gov
January 26, 2023	K223588	PALLAS Premium	GEX	Substantially Equivalent	Laseroptek Co., Ltd.	accessdata.fda.gov
June 9, 2022	K212663	HELIOS IV 785	GEX	Substantially Equivalent	Laseroptek Co., Ltd.	accessdata.fda.gov
December 8, 2021	K212573	PicoLO Premium	GEX	Substantially Equivalent	Laseroptek Co., Ltd.	accessdata.fda.gov
April 7, 2021	K203491	PicoLO Nd: YAG Picosecond Laser System	GEX	Substantially Equivalent	Laseroptek Co., Ltd.	accessdata.fda.gov
January 3, 2020	K191501	PALLAS 308/311 Solid-State UV Laser System	GEX	Substantially Equivalent	Laseroptek Co., Ltd.	accessdata.fda.gov
December 27, 2018	K182045	Lotus III Multi-Pulsed Er: Yag Laser System	GEX	Substantially Equivalent	Laseroptek Co., Ltd.	accessdata.fda.gov
June 2, 2016	K152856	Helios III	GEX	Substantially Equivalent	Laseroptek Co., Ltd.	accessdata.fda.gov
January 22, 2014	K132286	HYPERION LONG PULSED ND: YAG LASER	GEX	Substantially Equivalent	Scarlet Rf, Inc.	accessdata.fda.gov

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Updated February 7, 2025. 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.