DeviceClearance

Product code NIC— Ophthalmic

CHROMAGEN V3.0 READING AID SOFT CONTACT LENS

Classification name
Lens, Contact, For Reading Discomfort
Device class
Class 2
Regulation
21 CFR 886.5925
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NIC under 21 CFR 886.5925, via openFDA

Market context for product code NIC

FDA has cleared 1 device under product code NIC, all in 2002, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code NIC

Recent clearances under product code NIC

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