NJH

Lens, Spectacle (Prescription), For Reading Discomfort

Product code

NJH

Device name

Lens, Spectacle (Prescription), For Reading Discomfort

Device class

Class 1

21 CFR

21 CFR 886.5844

Medical specialty

Ophthalmic

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

FDA classification definition

Colored spectacle lenses 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).