De Novo DEN230083
- Device
- Valeda Light Delivery System
- Contact
- lori holder
- De Novo number
- DEN230083
- Product code
- SDE
- Regulation
- 886.5520
- Classification name
- light based device for dry age-related macular degeneration
- Decision
- granted (DENG)
- Decision date
- 2024-11-04
- Date received
- 2023-12-14
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Direct
Current FDA Classification#
- Product code
- SDE
- Device name
- Light Based Device For Dry Age-Related Macular Degeneration
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 886.5520
- Implant
- N
- Life sustain/support
- N