Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Wontech Co., Ltd. — Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
255 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252877 | SANDRO Dual | Wontech Co., Ltd. | 2025-12-19 | 100 | 0 |
| K250165 | Pastelle | Wontech Co., Ltd. | 2025-07-03 | 163 | 0 |
| K251288 | Veincare | Wontech Co., Ltd. | 2025-05-14 | 19 | 0 |
| K251094 | Alma Veil | Wontech Co., Ltd. | 2025-05-06 | 26 | 0 |
| K243957 | PICOALEX | Wontech Co., Ltd. | 2025-03-12 | 79 | 0 |
| K241527 | Pastelle Pro | Wontech Co., Ltd. | 2025-02-14 | 260 | 0 |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | Wontech Co., Ltd. | 2025-02-14 | 252 | 0 |
| K243929 | Oligio X | Wontech Co., Ltd. | 2025-01-21 | 32 | 0 |
| K241930 | Veincare | Wontech Co., Ltd. | 2024-11-14 | 136 | 0 |
| K241406 | Lavieen | Wontech Co., Ltd. | 2024-06-28 | 42 | 0 |
| K241144 | Picosecond Nd:YAG Laser (PICOCAREMAJESTY) | Wontech Co., Ltd. | 2024-06-24 | 60 | 0 |
| K234104 | PICOANDY (Q-Switched Nd:YAG Laser) | Wontech Co., Ltd. | 2024-03-15 | 80 | 0 |
| K240313 | Oligio X | Wontech Co., Ltd. | 2024-02-22 | 20 | 0 |
| K240064 | Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom | Wontech Co., Ltd. | 2024-02-07 | 29 | 0 |
| K232106 | Air Gap Fiber | Wontech Co., Ltd. | 2024-01-08 | 178 | 0 |
| K223727 | Lavieen | Wontech Co., Ltd. | 2023-08-25 | 255 | 0 |
| K231054 | V-Laser | Wontech Co., Ltd. | 2023-08-14 | 123 | 0 |
| K223862 | Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp | Wontech Co., Ltd. | 2023-04-28 | 126 | 0 |
| K221989 | The Oligio | Wontech Co., Ltd. | 2022-10-13 | 99 | 0 |
| K221427 | V-Laser | Wontech Co., Ltd. | 2022-08-24 | 100 | 0 |
| K212127 | Picocaremajesty | Wontech Co., Ltd. | 2022-01-07 | 184 | 0 |
| K201406 | Picowon | Wontech Co., Ltd. | 2020-07-22 | 55 | 0 |
| K200110 | SANDRO Dual | Wontech Co., Ltd. | 2020-03-16 | 59 | 0 |
| K192425 | Hair Boom 69, Hair Boom Air, Ulike Hair UpUp | Wontech Co., Ltd. | 2019-09-30 | 25 | 0 |
| K183563 | Holinwon 30 | Wontech Co., Ltd. | 2019-09-05 | 259 | 0 |
| K183156 | V-Laser | Wontech Co., Ltd. | 2019-04-24 | 160 | 0 |
| K181272 | Picocare Family | Wontech Co., Ltd. | 2018-07-31 | 78 | 0 |
| K162755 | Picocare | Wontech Co., Ltd. | 2017-06-12 | 255 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda