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De Novo DEN210005
- Device
- Luminopia One
- Contact
- scott xiao
- De Novo number
- DEN210005
- Product code
- QQU
- Regulation
- 886.5500
- Classification name
- digital therapy device for amblyopia
- Decision
- granted (DENG)
- Decision date
- 2021-10-20
- Date received
- 2021-03-01
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Direct
Current FDA Classification#
- Product code
- QQU
- Device name
- Digital Therapy Device For Amblyopia
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 886.5500
- Implant
- N
- Life sustain/support
- N