ClearanceBrief
Company ยท KR

Wontech Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2025. Name variants (Inc, Corp, punctuation) are merged.

30510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GEXPowered Laser Surgical Instrument22
OAPLaser, Comb, Hair5
GEIElectrosurgical, Cutting & Coagulation & Accessories3

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Dec 19, 2025K252877SANDRO Dual
Wontech Co., Ltd., KR
GEX
Jul 3, 2025K250165Pastelle
Wontech Co., Ltd., KR
GEX
May 14, 2025K251288Veincare
Wontech Co., Ltd., KR
GEX
May 6, 2025K251094Alma Veil
Wontech Co., Ltd., KR
GEX
Mar 12, 2025K243957PICOALEX
Wontech Co., Ltd., KR
GEX
Feb 14, 2025K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
Wontech Co., Ltd., KR
GEX
Feb 14, 2025K241527Pastelle Pro
Wontech Co., Ltd., KR
GEX
Jan 21, 2025K243929Oligio X
Wontech Co., Ltd., KR
GEI
Nov 14, 2024K241930Veincare
Wontech Co., Ltd., KR
GEX
Jun 28, 2024K241406Lavieen
Wontech Co., Ltd., KR
GEX
Jun 24, 2024K241144Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
Wontech Co., Ltd., KR
GEX
Mar 15, 2024K234104PICOANDY (Q-Switched Nd:YAG Laser)
Wontech Co., Ltd., KR
GEX
Feb 22, 2024K240313Oligio X
Wontech Co., Ltd., KR
GEI
Feb 7, 2024K240064Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
Wontech Co., Ltd., KR
OAP
Jan 8, 2024K232106Air Gap Fiber
Wontech Co., Ltd., KR
GEX
Aug 25, 2023K223727Lavieen
Wontech Co., Ltd., KR
GEX
Aug 14, 2023K231054V-Laser
Wontech Co., Ltd., KR
GEX
Apr 28, 2023K223862Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
Wontech Co., Ltd., KR
OAP
Oct 13, 2022K221989The Oligio
Wontech Co., Ltd., KR
GEI
Aug 24, 2022K221427V-Laser
Wontech Co., Ltd., KR
GEX
Jan 7, 2022K212127Picocaremajesty
Wontech Co., Ltd., KR
GEX
Jul 22, 2020K201406Picowon
Wontech Co., Ltd., KR
GEX
Mar 16, 2020K200110SANDRO Dual
Wontech Co., Ltd., KR
GEX
Sep 30, 2019K192425Hair Boom 69, Hair Boom Air, Ulike Hair UpUp
Wontech Co., Ltd., KR
OAP
Sep 5, 2019K183563Holinwon 30
Wontech Co., Ltd., KR
GEX
Jul 29, 2019K191154Hair Boom 69
Wontech, KR
OAP
Apr 24, 2019K183156V-Laser
Wontech Co., Ltd., KR
GEX
Nov 16, 2018K182562Hair Boom 69
Wontech, KR
OAP
Jul 31, 2018K181272Picocare Family
Wontech Co., Ltd., KR
GEX
Jun 12, 2017K162755Picocare
Wontech Co., Ltd., KR
GEX

Latest recalls

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