PICOALEX
Wontech Co., Ltd.
WONTECH INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014218989 | 3014218989 | WONTECH INC. | 1 | Y | 2026-01-01 | 500 W. Office Center Drive. Suite # 400-4108 Fort Washington PA US 19034 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 218334 | 1154597537 | K183156 | V-Laser | GEX | 2019-04-24 |
| 218334 | 1875381614 | K182562 | Hair Boom 69 | OAP | 2018-11-16 |
| 218334 | 2072719125 | K181272 | Picocare Family | GEX | 2018-07-31 |
| 218334 | 1601297585 | K162755 | Picocare | GEX | 2017-06-12 |
| 218334 | 1084721035 | K123293 | PASTELLE Q-SWITCHED ND: YAG LASER | GEX | 2013-04-11 |
| 218334 | 2039074044 | K080697 | SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER | GEX | 2008-04-07 |
Product Codes Associated With Registrations#
PMN#
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
Wontech Co., Ltd.
Pastelle Pro
Wontech Co., Ltd.
Oligio X
Wontech Co., Ltd.
Veincare
Wontech Co., Ltd.
Lavieen
Wontech Co., Ltd.
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
Wontech Co., Ltd.
PICOANDY (Q-Switched Nd:YAG Laser)
Wontech Co., Ltd.
Oligio X
Wontech Co., Ltd.
Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
Wontech Co., Ltd.
Air Gap Fiber
Wontech Co., Ltd.
Lavieen
Wontech Co., Ltd.
V-Laser
Wontech Co., Ltd.
Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
Wontech Co., Ltd.
Hair Boom 69
Wontech
V-Laser
WONTECH Co., Ltd.
Hair Boom 69
WonTech
GUDID#
SANDRO Dual - The SANDRO Dual Laser System is Nd:YAG and Alexandrite laser system.
2020-06-16
Cosjet SR - Long Pulse Nd:YAG Laser
2017-08-16
Picowon - Alexandrite laser System
2020-10-06
Pastelle - Q-switched Nd:YAG Laser
2017-08-16
PICOALEX - Alexandrite laser System
2025-03-25
The Oligio - Radio Frequency Therapy System
2023-02-17
Oligio X - Radio Frequency Therapy System
2024-03-21
ALMA VEIL; V-Laser - Long pulsed Nd:YAG Laser System
2023-08-24
Veincare - Surgical Diode Laser System
2024-12-17
Pastelle Pro - Q-switched Nd:YAG Laser
2025-02-24
WONTECH Surgical Optic Fibers - BA600R of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
2025-02-24
WONTECH Surgical Optic Fibers - BA400R of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
2025-02-24
WONTECH Surgical Optic Fibers - BA600 of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
2025-02-24
WONTECH Surgical Optic Fibers - BA400 of Surgical Optic Fiber Series(BA400/BA400R/BA600/BA600R)
2025-02-24
NOUVADerm - Tm-doped Fiber Laser System
2024-10-04
Lavieen - Tm-doped Fiber Laser System
2023-09-20
PICOCAREMAJESTY - Q-switched Nd:YAG Laser
2022-02-01
PICOANDY - Q-switched Nd:YAG Laser
2024-03-21
V-Laser - Long pulsed Nd:YAG Laser System
2019-05-21
Hair Boom69, Hair Beam Air, Hair Boom, Hair Boom Air, Ulike Hair UpUp - Low level laser therapy device.
2019-10-28
Air Gap Fiber - AG275 of Air Gap Fiber Series AG550, AG365, AG275
2024-02-05
Air Gap Fiber - AG365 of Air Gap Fiber Series AG550, AG365, AG275
2024-02-01
Air Gap Fiber - AG550 of Air Gap Fiber Series AG550, AG365, AG275
2024-02-01
Hair Boom - Low level laser therapy device
2019-04-15
Hair Boom69, Hair Boom - Low level laser therapy device.
2019-10-28
Picocare Family, Picocare450 - Q-Switched Nd:YAG Laser
2020-06-16
Picocare - Q-switched Nd:YAG Laser
2017-08-11
Holinwon 30, HolinWON Prima - Holmium Laser
2020-06-16