Product code NIC

Device name

Lens, Contact, For Reading Discomfort

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.5925

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset