Skip to contentDe Novo DEN250016
- Device
- Essilor® Stellest®
- Contact
- john anderson
- De Novo number
- DEN250016
- Product code
- QUR
- Regulation
- 886.5845
- Classification name
- prescription spectacle lenses to reduce the progression of myopia
- Decision
- granted (DENG)
- Decision date
- 2025-09-25
- Date received
- 2025-04-28
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Direct
Current FDA Classification#
- Product code
- QUR
- Device name
- Prescription Spectacle Lenses To Reduce The Progression Of Myopia
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 886.5845
- Implant
- N
- Life sustain/support
- N