Largan Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Largan Medical Co., Ltd.” (first 2017, latest 2025), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 92 days. Since 2017 the median was 92 days, against 146 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 | 231 |
| 2018 | 4 | 48 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 244 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 269 |
| 2025 | 1 | 133 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Largan Medical Co., Ltd. took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 146 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 7 | 7 |
| MNR | Ventilatory Effort Recorder | 1 | 1 |
Review panels
- Ophthalmic (7)
- Anesthesiology (1)
Most recent Largan Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242916 | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | LPL | 2025-02-04 | 133 |
| K233501 | LARGAN Health AI-Tech Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) | MNR | 2024-07-26 | 269 |
| K202129 | Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo | LPL | 2021-04-01 | 244 |
| K182674 | Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia | LPL | 2018-11-13 | 48 |
| K182523 | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens | LPL | 2018-11-01 | 49 |
| K181232 | Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia | LPL | 2018-06-29 | 51 |
| K181230 | Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA | LPL | 2018-06-25 | 47 |
| K170286 | Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA | LPL | 2017-09-18 | 231 |
Recalls
openFDA lists no recalls under a recalling firm named Largan Medical 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 Largan Medical Co., Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03413085: To Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control (Completed, started 2018-05-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Largan Medical Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Largan Medical Co., Ltd.” (first 2017, latest 2025), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Largan Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Largan Medical Co., Ltd. is 92 days. Since 2017: 92 days, versus 146 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Largan Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are LPL (Lenses, Soft Contact, Daily Wear, 7); MNR (Ventilatory Effort Recorder, 1).
Next steps
- See all 8 Largan Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LPL, Largan Medical 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.