Data / Medical devices / United States / Lumithera, Inc.
Lumithera, Inc.: FDA-registered device maker in Fort Worth, TX, United States, 1 510(k) clearance
Lumithera, Inc. is registered with the FDA (registration 3016232028) in Fort Worth, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 4, 2024. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016232028
- Address
- 6201 South Fwy, Fort Worth, TX, United States, 76134
- Owner or operator
- Alcon Laboratories, Inc. (1610287)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- December 4, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light Based Device For Dry Age-Related Macular Degeneration | SDE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 4, 2024 | DEN230083 | Valeda Light Delivery System | SDE | Unknown | Lumithera, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 7, 2025 | 96892 | Class III | Ongoing | Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No | U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet. | accessdata.fda.gov |
Compare with other makers
Updated June 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.