FDA product code QUR

Prescription Spectacle Lenses To Reduce The Progression Of Myopia

Ophthalmic·Class 2·21 CFR 886.5845
US regulatory classifications
US Product Code (FDA)
QUR
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 886.5845
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Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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.

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About this record

Prescription Spectacle Lenses To Reduce The Progression Of Myopia is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.