Data / Medical devices / South Korea / WONTECH Co., Ltd.

WONTECH Co., Ltd.: FDA-registered device maker in Daejeon, South Korea, 32 510(k) clearances

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

WONTECH Co., Ltd. is registered with the FDA (registration 3006985208) in Daejeon, South Korea. It lists 3 device types. The FDA files 32 510(k) clearances under its listings, the newest dated December 19, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch WONTECH Co., Ltd.

FDA registration number: 3006985208
Address: 64, Techno 8-ro, Yuseong-gu, Daejeon, South Korea, 305-500
Owner or operator: WONTECH Co., Ltd. (10025342)
Roles: Manufacturer
First device listed: April 8, 2008
Registered through: 2026
Brand names listed: AG275, AG365, AG550, ALMA VEIL, Air Gap Fiber, Bare/Radial Fiber, Cosjet SR, Hair Beam and more

Devices it lists

Device	Product code	Class	Role	Source
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Laser, Comb, Hair	OAP	2	Manufacturer	accessdata.fda.gov
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
December 19, 2025	K252877	SANDRO Dual	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
July 3, 2025	K250165	Pastelle	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
May 14, 2025	K251288	Veincare	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
May 6, 2025	K251094	Alma Veil	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
March 12, 2025	K243957	PICOALEX	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
February 14, 2025	K241643	WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
February 14, 2025	K241527	Pastelle Pro	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
January 21, 2025	K243929	Oligio X	GEI	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
November 14, 2024	K241930	Veincare	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
June 28, 2024	K241406	Lavieen	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
June 24, 2024	K241144	Picosecond Nd:YAG Laser (PICOCAREMAJESTY)	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
March 15, 2024	K234104	PICOANDY (Q-Switched Nd:YAG Laser)	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
February 22, 2024	K240313	Oligio X	GEI	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
February 7, 2024	K240064	Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom	OAP	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
January 8, 2024	K232106	Air Gap Fiber	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
August 25, 2023	K223727	Lavieen	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
August 14, 2023	K231054	V-Laser	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
April 28, 2023	K223862	Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp	OAP	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
October 13, 2022	K221989	The Oligio	GEI	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
August 24, 2022	K221427	V-Laser	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
January 7, 2022	K212127	Picocaremajesty	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
July 22, 2020	K201406	Picowon	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
March 16, 2020	K200110	SANDRO Dual	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
September 30, 2019	K192425	Hair Boom 69, Hair Boom Air, Ulike Hair UpUp	OAP	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
September 5, 2019	K183563	Holinwon 30	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
July 29, 2019	K191154	Hair Boom 69	OAP	Substantially Equivalent	Wontech	accessdata.fda.gov
April 24, 2019	K183156	V-Laser	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
November 16, 2018	K182562	Hair Boom 69	OAP	Substantially Equivalent	Wontech	accessdata.fda.gov
July 31, 2018	K181272	Picocare Family	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
June 12, 2017	K162755	Picocare	GEX	Substantially Equivalent	Wontech Co., Ltd.	accessdata.fda.gov
April 11, 2013	K123293	PASTELLE Q-SWITCHED ND: YAG LASER	GEX	Substantially Equivalent	Won Technology Co., Ltd.	accessdata.fda.gov
April 7, 2008	K080697	SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER	GEX	Substantially Equivalent	Global USA Distribution, LLC	accessdata.fda.gov

Compare with other makers

Updated December 19, 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.