DEN250016
- 510(k) number
- DEN250016
- Device name
- Essilor® Stellest®
- Applicant
- Essilor Of America, Inc. TX · US
- Product code
- QUR — Prescription Spectacle Lenses To Reduce The Progress
- Decision date
- 2025-09-25
- Date received
- 2025-04-28
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Ophthalmic
Official FDA record: DEN250016
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.