Product areas
FDA product code distribution
Wontech Co., Ltd.
Country / region:Korea, Republic of (KR)
510(k) submissions
22
Filtered: GEX
Latest clearance
2025-12-19
Product codes
1
GEX
510(k) submissions
22 total · filtered by GEX
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K252877 | SANDRO Dual | GEX | Class 2 | 2025-12-19 |
| K250165 | Pastelle | GEX | Class 2 | 2025-07-03 |
| K251288 | Veincare | GEX | Class 2 | 2025-05-14 |
| K251094 | Alma Veil | GEX | Class 2 | 2025-05-06 |
| K243957 | PICOALEX | GEX | Class 2 | 2025-03-12 |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | GEX | Class 2 | 2025-02-14 |
| K241527 | Pastelle Pro | GEX | Class 2 | 2025-02-14 |
| K241930 | Veincare | GEX | Class 2 | 2024-11-14 |
| K241406 | Lavieen | GEX | Class 2 | 2024-06-28 |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY) | GEX | Class 2 | 2024-06-24 |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser) | GEX | Class 2 | 2024-03-15 |
| K232106 | Air Gap Fiber | GEX | Class 2 | 2024-01-08 |
| K223727 | Lavieen | GEX | Class 2 | 2023-08-25 |
| K231054 | V-Laser | GEX | Class 2 | 2023-08-14 |
| K221427 | V-Laser | GEX | Class 2 | 2022-08-24 |
| K212127 | Picocaremajesty | GEX | Class 2 | 2022-01-07 |
| K201406 | Picowon | GEX | Class 2 | 2020-07-22 |
| K200110 | SANDRO Dual | GEX | Class 2 | 2020-03-16 |
| K183563 | Holinwon 30 | GEX | Class 2 | 2019-09-05 |
| K183156 | V-Laser | GEX | Class 2 | 2019-04-24 |
| K181272 | Picocare Family | GEX | Class 2 | 2018-07-31 |
| K162755 | Picocare | GEX | Class 2 | 2017-06-12 |
Company profile
- Canonical name
- Wontech Co., Ltd.
- Country
- Korea, Republic of(KR)
Cited predicates
44- K231791
PENTO Nd:YAG and Alexandrite laser system
- K200110
SANDRO Dual
- K201111
GentleMax Pro Plus
- K232106
Air Gap Fiber
- K241643
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
- K241930
Veincare
- K231054
V-Laser
- K123293
—
—
Not ingested - K213569
HOLLYWOOD SPECTRA Laser System
- K241529
—
—
Not ingested - K210226
PicoSure Workstation
- K160549
MEDICAL DIODE LASER SYSTEMS
- K181632
Venacure 1470 Pro
- K232106
Air Gap Fiber
- K220189
LISA Laser Surgical Fibers
- K161670
Lucid Q-PTP / HWA 55
- K213569
HOLLYWOOD SPECTRA Laser System
- K213567
—
—
Not ingested - K202503
Chrome
- K173002
2940 nm Er:Yag Laser Handpiece
- K223727
Lavieen
- K234104
PICOANDY (Q-Switched Nd:YAG Laser)
- K201773
PICOHI
- K181272
Picocare Family
- K212127
Picocaremajesty
- K212127
Picocaremajesty
- K201773
PICOHI
- K181272
Picocare Family
- K170366
Laser Peripherals, LLC Family of Bare Laser Fibers
- K153671
Family of CoolGlide Aesthetic Lasers
- K221427
V-Laser
- K171009
LASEMD Laser System
- K182173
Joule System
- K183156
V-Laser
- K181272
Picocare Family
- K200166
—
—
Not ingested - K200116
PicoSecond Nd: YAG Laser System
- K121346
—
—
Not ingested - K041660
—
—
Not ingested - K050738
—
—
Not ingested - K153671
Family of CoolGlide Aesthetic Lasers
- K153527
PicoWay Laser System
- K162755
Picocare
- K140727
—
—
Not ingested
Wontech Co., Ltd. references 44 predicate/reference devices
Cited as predicate
30- K260017
Picosecond Nd:YAG Laser Systems (Model: HS-298)
- K260017
Picosecond Nd:YAG Laser Systems (Model: HS-298)
- K253829
Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
- K253828
Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
- K253344
BELLUS-Q
- K252877
SANDRO Dual
- K252745
Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
- K252732
1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
- K251981
Boston PICO (Boston PICO)
- K251919
Thulium Laser System (Deluxlase)
- K251464
TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)
- K251288
Veincare
- K251288
Veincare
- K251288
Veincare
- K251094
Alma Veil
- K241930
Veincare
- K241406
Lavieen
- K241144
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
- K241144
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
- K241144
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
- K234104
PICOANDY (Q-Switched Nd:YAG Laser)
- K234104
PICOANDY (Q-Switched Nd:YAG Laser)
- K233024
Alma Harmony
- K233018
PICOSECOND Nd:YAG Laser System
- K233007
Picosecond Nd:YAG Laser System; PICO LEGEND
- K231054
V-Laser
- K221427
V-Laser
- K212127
Picocaremajesty
- K192583
PicoLazer Laser System
- K181272
Picocare Family
30 submissions cite Wontech Co., Ltd. as a predicate