WONTECH Co., Ltd.
Daejeon, KR
WONTECH Co., Ltd. appears in FDA device records in Daejeon, KR. FDA records list 30 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 30 510(k) clearances for WONTECH Co., Ltd. between 2017 and 2025. The busiest year on record is 2025, with 8. The most recent is 2025, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 4 |
| 2020 | 2 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 7 |
| 2025 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252877 | SANDRO Dual | GEX | Substantially Equivalent | |
| K250165 | Pastelle | GEX | Substantially Equivalent | |
| K251288 | Veincare | GEX | Substantially Equivalent | |
| K251094 | Alma Veil | GEX | Substantially Equivalent | |
| K243957 | PICOALEX | GEX | Substantially Equivalent | |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | GEX | Substantially Equivalent | |
| K241527 | Pastelle Pro | GEX | Substantially Equivalent | |
| K243929 | Oligio X | GEI | Substantially Equivalent | |
| K241930 | Veincare | GEX | Substantially Equivalent | |
| K241406 | Lavieen | GEX | Substantially Equivalent | |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY) | GEX | Substantially Equivalent | |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser) | GEX | Substantially Equivalent | |
| K240313 | Oligio X | GEI | Substantially Equivalent | |
| K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | OAP | Substantially Equivalent | |
| K232106 | Air Gap Fiber | GEX | Substantially Equivalent | |
| K223727 | Lavieen | GEX | Substantially Equivalent | |
| K231054 | V-Laser | GEX | Substantially Equivalent | |
| K223862 | Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp | OAP | Substantially Equivalent | |
| K221989 | The Oligio | GEI | Substantially Equivalent | |
| K221427 | V-Laser | GEX | Substantially Equivalent | |
| K212127 | Picocaremajesty | GEX | Substantially Equivalent | |
| K201406 | Picowon | GEX | Substantially Equivalent | |
| K200110 | SANDRO Dual | GEX | Substantially Equivalent | |
| K192425 | Hair Boom 69, Hair Boom Air, Ulike Hair UpUp | OAP | Substantially Equivalent | |
| K183563 | Holinwon 30 | GEX | Substantially Equivalent | |
| K191154 | Hair Boom 69 | OAP | Substantially Equivalent | |
| K183156 | V-Laser | GEX | Substantially Equivalent | |
| K182562 | Hair Boom 69 | OAP | Substantially Equivalent | |
| K181272 | Picocare Family | GEX | Substantially Equivalent | |
| K162755 | Picocare | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006985208 | 3006985208 | WONTECH Co., Ltd. | 64, Techno 8-ro, Yuseong-gu, Daejeon 305-500 KR | 2026 | |
| 3014218989 | 3014218989 | WONTECH INC. | 500 W. Office Center Drive., Fort Washington, PA 19034 US | 2026 | No device listings on this registration |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain