Product code QUR

Device name

Prescription Spectacle Lenses To Reduce The Progression Of Myopia

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.5845

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset