Wontech Co., Ltd.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Wontech Co., Ltd.” (first 2017, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Since 2017 the median was 100 days, against 96 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 255 |
| 2018 | 1 | 78 |
| 2019 | 3 | 160 |
| 2020 | 2 | 57 |
| 2021 | 0 | — |
| 2022 | 3 | 100 |
| 2023 | 3 | 126 |
| 2024 | 7 | 60 |
| 2025 | 8 | 90 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wontech Co., Ltd. took a median 100 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 22 | 22 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| OAP | Laser, Comb, Hair | 3 | 3 |
Review panels
Most recent Wontech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252877 | SANDRO Dual | GEX | 2025-12-19 | 100 |
| K250165 | Pastelle | GEX | 2025-07-03 | 163 |
| K251288 | Veincare | GEX | 2025-05-14 | 19 |
| K251094 | Alma Veil | GEX | 2025-05-06 | 26 |
| K243957 | PICOALEX | GEX | 2025-03-12 | 79 |
| K241643 | WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) | GEX | 2025-02-14 | 252 |
| K241527 | Pastelle Pro | GEX | 2025-02-14 | 260 |
| K243929 | Oligio X | GEI | 2025-01-21 | 32 |
| K241930 | Veincare | GEX | 2024-11-14 | 136 |
| K241406 | Lavieen | GEX | 2024-06-28 | 42 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Wontech Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Wontech (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wontech Co., Ltd.?
FDA lists 28 510(k) clearances under the applicant name “Wontech Co., Ltd.” (first 2017, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Wontech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wontech Co., Ltd. is 100 days. Since 2017: 100 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wontech Co., Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 22); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); OAP (Laser, Comb, Hair, 3).
Next steps
- See all 28 Wontech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Wontech Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.