Nu Eyne Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nu Eyne Co., Ltd.” (first 2019, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 87 days. Since 2017 the median was 87 days, against 116 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 |
|---|---|---|
| 2019 | 1 | 67 |
| 2020 | 0 | — |
| 2021 | 1 | 87 |
| 2022 | 0 | — |
| 2023 | 1 | 452 |
| 2024 | 1 | 57 |
| 2025 | 1 | 90 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nu Eyne Co., Ltd. took a median 87 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 3 | 3 |
| QGL | Transcutaneous Nerve Stimulator For Adhd | 2 | 2 |
Review panels
- Neurology (5)
Most recent Nu Eyne Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243289 | ADDNOX (BPSPM1) | QGL | 2025-01-16 | 90 |
| K242719 | ELEXIR 2.0 (ALLIVE3) | PCC | 2024-11-06 | 57 |
| K213629 | SMILE | QGL | 2023-02-12 | 452 |
| K211380 | Elexir | PCC | 2021-07-30 | 87 |
| K192773 | ALLIVE | PCC | 2019-12-06 | 67 |
Recalls
openFDA lists no recalls under a recalling firm named Nu Eyne 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 Nu Eyne Co., Ltd. is the lead sponsor of 6 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07079215: Evaluation of a Physical Device for Medical Use (ADTPM 1) for Opioid Withdrawal Symptoms (Recruiting, started 2025-05-30)
- NCT05301920: The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Migraine (Completed, started 2021-10-08)
- NCT05203796: The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Dry Eye Disease (Completed, started 2021-08-23)
- NCT05159414: Study of Application of Pulse Electrical Stimulation Around Eye in Glaucoma Patients (Completed, started 2021-05-04)
- NCT05291078: Study of Application of Transcutaneous Trigeminal Nerve Stimulation and Sound Fusion Stimulation on Tinnitus (Completed, started 2020-10-22)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nu Eyne Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Nu Eyne Co., Ltd.” (first 2019, latest 2025), across 2 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 Nu Eyne Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nu Eyne Co., Ltd. is 87 days. Since 2017: 87 days, versus 116 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nu Eyne Co., Ltd.?
The most frequent FDA product codes under this applicant name are PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine, 3); QGL (Transcutaneous Nerve Stimulator For Adhd, 2).
Next steps
- See all 5 Nu Eyne Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code PCC, Nu Eyne 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.