Unicon Optical Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Unicon Optical Co., Ltd.” (first 2014, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 94 days. Since 2017 the median was 86 days, against 113 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 |
|---|---|---|
| 2014 | 1 | 94 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 145 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 111 |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Unicon Optical Co., Ltd. took a median 86 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 113 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 5 | 5 |
Review panels
- Ophthalmic (5)
Most recent Unicon Optical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241707 | OCuSOFT AMENITY (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL | LPL | 2024-07-12 | 29 |
| K213216 | Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens | LPL | 2022-01-18 | 111 |
| K191929 | UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | LPL | 2019-09-17 | 60 |
| K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac | LPL | 2019-05-16 | 230 |
| K141917 | UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR | LPL | 2014-10-17 | 94 |
Recalls
openFDA lists no recalls under a recalling firm named Unicon Optical 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.
Device clinical trials
An industry sponsor named Unicon Optical Co., Ltd. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07322211: A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses (Recruiting, started 2026-01-20)
- NCT04295499: Safety and Effectiveness of the Qualis Contact Lens (Completed, started 2020-07-01)
Frequently asked questions
How many FDA 510(k) clearances are listed under Unicon Optical Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Unicon Optical Co., Ltd.” (first 2014, latest 2024), across 1 product code 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 Unicon Optical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Unicon Optical Co., Ltd. is 94 days. Since 2017: 86 days, versus 113 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Unicon Optical Co., Ltd.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 5).
Next steps
- See all 5 Unicon Optical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Unicon Optical 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.