QUR · Class II · 21 CFR 886.5845

FDA Product Code QUR: Prescription Spectacle Lenses To Reduce The Progression Of Myopia

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 Children Who Have Myopia To Reduce The Rate Of Myopia Progression. The Lenses Are Mounted Within A Spectacle Frame Classified Under § 886.5842.

Leading manufacturers include Essilor of America, Inc..

1
Total
0
Cleared
150d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared Prescription Spectacle Lenses To Reduce The Progression Of Myopia Devices (Product Code QUR)

1 devices
1–1 of 1
Not Cleared Sep 25, 2025
Essilor® Stellest®
DEN250016
Essilor of America, Inc.
Ophthalmic · 150d

About Product Code QUR - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QUR since 2025, with 0 receiving FDA clearance (average review time: 150 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

QUR devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →