Lumithera, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Lumithera, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SDE | Light Based Device For Dry Age-Related Macular Degeneration | 1 | 0 |
Review panels
- Ophthalmic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230083 | De Novo | Light Based Device For Dry Age-Related Macular Degeneration | 2024-11-04 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-05-07.
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 Lumithera, Inc. is the lead sponsor of 5 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06351605: A Registry Study to Assess Photobiomodulation in Dry Age-Related Macular Degeneration (EUROLIGHT) (EUROLIGHT) (Recruiting, started 2023-09-01)
- NCT04522999: Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration (Completed, started 2020-08-20)
- NCT04065490: Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III) (Active not recruiting, started 2019-09-01)
- NCT03878420: Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE II) (Completed, started 2019-02-14)
- NCT02725762: Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (Completed, started 2016-03)
Frequently asked questions
How many FDA 510(k) clearances are listed under Lumithera, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Lumithera, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Lumithera, Inc.?
The most frequent FDA product codes under this applicant name are SDE (Light Based Device For Dry Age-Related Macular Degeneration, 1).
Next steps
- See all 0 Lumithera, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SDE, Lumithera, Inc.'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.