DEN230083 is an FDA 510(k) submission for the Valeda Light Delivery System. This device is classified as a Light Based Device For Dry Age-related Macular Degeneration (Class II - Special Controls, product code SDE).
Submitted by Lumithera, Inc. (Poulsbo, US). The FDA issued a Not Cleared (DENG) decision on November 4, 2024.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5520. A Light Based Device For Dry Age-related Macular Degeneration Is A Prescription Device Intended For Use In The Application Of Non- Coherent Light Energy To The Eye. The Device Treats Or Improves Visual Acuity In Patients With Dry Age-related Macular Degeneration..
| 510(k) Number | DEN230083 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | December 14, 2023 |
| Decision Date | November 04, 2024 |
| Days to Decision | 326 days |
| Submission Type | Direct |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | SDE - Light Based Device For Dry Age-related Macular Degeneration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5520 |
| Definition | A Light Based Device For Dry Age-related Macular Degeneration Is A Prescription Device Intended For Use In The Application Of Non- Coherent Light Energy To The Eye. The Device Treats Or Improves Visual Acuity In Patients With Dry Age-related Macular Degeneration. |