QUR

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Prescription Spectacle Lenses To Reduce The Progression Of Myopia

Device class

Class II (moderate risk)

Regulation

21 CFR 886.5845

Medical specialty

Ophthalmic

FDA 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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