QUR · Prescription Spectacle Lenses To Reduce The Progression Of Myopia

Ophthalmic · 21 CFR 886.5845 · Class 2

Overview

Identification

Prescription spectacle lenses to reduce the progression of myopia consist of spectacle lenses with additional physical optical design lens elements. In addition to optical correction of myopic refractive error, these lenses are intended to be used by patients who have myopia to reduce the rate of myopia progression. The Essilor® Stellest® features concentric rings of aspheric lenslets (small lenses) which focus portions of the incoming light in front of the retina, causing blur on the retina, and 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.

Classification Rationale

Class II (special controls). The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, and there is sufficient information to establish special controls to mitigate the risks to health.

Special Controls

In combination with the general controls of the FD&C Act, the prescription spectacle lenses to reduce the progression of myopia are subject to the following special controls:

Recent Cleared Devices (1 of 1)

Top Applicants

• Essilor Of America, Inc. — 1 clearance