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NJHClass I

Lens, Spectacle (Prescription), For Reading Discomfort

21 CFR 886.5844 / Ophthalmic
FDA source (opens on fda.gov)

NJH is the FDA product code for Lens, Spectacle (Prescription), For Reading Discomfort, a class I device type, regulated under 21 CFR 886.5844. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NJH
Device name
Lens, Spectacle (Prescription), For Reading Discomfort
FDA 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.
Regulation
21 CFR 886.5844
Device class
Class I
Review panel
Ophthalmic
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code NJH

By decision year
2 clearances under product code NJH with a decision year between 1985 and 2002, 1985 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NJH by decision year
YearClearances
19851
20021

Applicants with the most clearances

Product code NJH
Applicants holding the most 510(k) clearances under product code NJH
ApplicantClearances
Cantor & Nissel, Ltd.1
Golden Dental Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 251 companies shown, in name order