Clearance Summary
Essilor® Stellest® received FDA 510(k) clearance under submission number DEN250016, sponsored by Essilor Of America, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2025-09-25.
- Submission: DEN250016
- Applicant / Sponsor: Essilor Of America, Inc.
- Clearance pathway: Direct
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5845
- Decision date: 2025-09-25
Classification & Regulation
This clearance is catalogued under FDA product code QUR and 21 CFR 886.5845, within the Ophthalmic review panel as a Class II device.