DEN230083
- 510(k) number
- DEN230083
- Device name
- Valeda Light Delivery System
- Applicant
- Lumithera, Inc. WA · US
- Product code
- SDE — Light Based Device For Dry Age-Related Macular Degen
- Decision date
- 2024-11-04
- Date received
- 2023-12-14
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Ophthalmic
Official FDA record: DEN230083
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.