510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NICClass II

Lens, Contact, For Reading Discomfort

21 CFR 886.5925 / Ophthalmic
FDA source (opens on fda.gov)

NIC is the FDA product code for Lens, Contact, For Reading Discomfort, a class II device type, regulated under 21 CFR 886.5925. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
NIC
Device name
Lens, Contact, For Reading Discomfort
FDA 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.
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code NIC

By decision year
1 clearance under product code NIC with a decision year between 2002 and 2002, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NIC by decision year
YearClearances
20021

Applicants with the most clearances

Product code NIC
Applicants holding the most 510(k) clearances under product code NIC
ApplicantClearances
Cantor & Nissel, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code