NIC

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Lens, Contact, For Reading Discomfort

Device class

Class II (moderate risk)

Regulation

21 CFR 886.5925

Medical specialty

Ophthalmic

Flags

Third-party review eligible

FDA definition

This lens is indicated for daily wear for the correction of refractive ametropia in persons with non-diseased eyes. This lens may also be prescribed as a colored filter to aid individuals who experience reading discomfort not related to binocular vision problems or uncorrected refractive error.

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