DeviceClearance

Product code NJH— Ophthalmic

CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS

Classification name
Lens, Spectacle (Prescription), For Reading Discomfort
Device class
Class 1
Regulation
21 CFR 886.5844
Advisory panel
Ophthalmic
Total cleared
2
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NJH under 21 CFR 886.5844, via openFDA

Market context for product code NJH

FDA has cleared 2 devices under product code NJH between 1985 and 2002, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code NJH

Recent clearances under product code NJH

Data sourced from openFDA. This site is unofficial and independent of the FDA.