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510(k) Data Aggregation

    K Number
    DEN250016

    Validate with FDA (Live)

    Date Cleared
    2025-09-25

    (150 days)

    Product Code
    Regulation Number
    886.5845
    Type
    Direct
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended 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 the 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.

    Device Description

    The Essilor® Stellest® is a prescription only (Rx only) device that is a pair of spectacle lenses fitted with the patient's refractive prescription. The unique features of this device are concentric rings of aspheric lenslets (small lenses) which focus portions of the incoming light in front of the retina, causing blur on the retina. The figure below shows a single lens where the 9mm diameter central zone is free from lenslets and 11 concentric lenslet rings are visible. Each ring has a slightly different focusing power. The device is designed to slow the elongation of the eye and a provide a reduction in the progression of myopia in myopic children.

    The Essilor® Stellest® spectacle lenses are intended to be worn by a pediatric patient in a spectacle frame, as eyeglasses are worn. There is no specific frame that comes with the Essilor® Stellest® lenses. Rather, the Essilor® Stellest® lenses are mounted into a chosen spectacle frame, based on patient preference in conjunction with their healthcare provider or optician. The Essilor® Stellest® lenses are made from polycarbonate with Crizal® Easy Pro coating, an anti-reflectance coating, and are not tinted. Labeling for the Essilor® Stellest® device is provided to both the healthcare provider/optician and the pediatric patient/caregiver(s).

    AI/ML Overview

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