Luminopia, Inc.: FDA clearances and approvals
Luminopia, Inc. has 3 FDA 510(k) clearances (first 2022, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time: 149 days. Since 2017 its median was 149 days, against 144 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2022 | 1 | 149 |
| 2023 | 0 | — |
| 2024 | 1 | 261 |
| 2025 | 1 | 118 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Luminopia, Inc.'s cleared 510(k)s took a median 149 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QQU | Digital Therapy Device For Amblyopia | 4 | 3 |
Review panels
- Ophthalmic (4)
Most recent Luminopia, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243819 | Luminopia | QQU | 2025-04-09 | 118 |
| K233720 | Luminopia | QQU | 2024-08-08 | 261 |
| K221659 | Luminopia One | QQU | 2022-11-04 | 149 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210005 | De Novo | Digital Therapy Device For Amblyopia | 2021-10-20 |
Recalls
openFDA lists no recalls under a recalling firm named Luminopia, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Luminopia, Inc. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06429280: Clinical Data Registry of Amblyopia Patients on Luminopia Treatment (Recruiting, started 2023-09-01)
- NCT03608150: Luminopia One Amblyopia Vision Improvement Study (Completed, started 2019-01-16)
- NCT02782117: Luminopia One Pilot Study (Completed, started 2017-08-01)
Frequently asked questions
How many FDA 510(k) clearances does Luminopia, Inc. have?
Luminopia, Inc. has 3 FDA 510(k) clearances (first 2022, latest 2025), plus 1 De Novo decision, across 1 product code in 1 review panel.
How long does FDA take to clear Luminopia, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Luminopia, Inc.'s cleared 510(k)s is 149 days. Since 2017: 149 days, versus 144 days for all cleared 510(k)s in the same product codes.
What devices does Luminopia, Inc. make?
Its most frequent FDA product codes are QQU (Digital Therapy Device For Amblyopia, 4).
Has Luminopia, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Luminopia, Inc. Related entities may recall under other names.
Next steps
- See all 3 Luminopia, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QQU, Luminopia, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.