# DEN250016: Essilor® Stellest®

- Pathway: De Novo (Direct)
- Applicant: Essilor Of America, Inc.
- Decided: Sep 25, 2025 after 150 days
- Product code: QUR (Prescription Spectacle Lenses To Reduce The Progression Of Myopia)
- Device class: 2
- Regulation: 21 CFR 886.5845
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
The Essilor® Stellest® lens is indicated for the correction of myopia with and without astigmatism and for slowing the progression of myopia in children with non-diseased eyes, who, at initiation of treatment, are aged 6-12 years and have spherical equivalent refraction of -0.75 D to -4.50 D with astigmatism up to 1.50 D.

Source page: https://510kreport.com/device/DEN250016
Methodology: https://510kreport.com/methodology