FDA product code NJH: Lens, Spectacle (Prescription), For Reading Discomfort
NJH is the FDA product code for lens, spectacle (prescription), for reading discomfort. It is a Class I device, regulated under 21 CFR 886.5844 and reviewed by the Ophthalmic panel. FDA has cleared 2 510(k) submissions under NJH, from 2 different applicants. The average 510(k) review took 81 days (median 81).
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.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Spectacle (Prescription), For Reading Discomfort |
| Device class | Class I |
| Regulation | 21 CFR 886.5844 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NJH clearance
Top NJH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cantor & Nissel , Ltd. | 1 | 2002-10-07 |
| Golden Dental Products, Inc. | 1 | 1985-12-03 |
Most recent NJH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022373 | Cantor & Nissel , Ltd. | CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS | 2002-10-07 | 77 |
| K853758 | Golden Dental Products, Inc. | PY-RITE | 1985-12-03 | 85 |
Recalls for NJH devices
openFDA lists no recalls for product code NJH.
Frequently asked questions
What is FDA product code NJH?
NJH is the FDA product code for lens, spectacle (prescription), for reading discomfort. It is a Class I device, regulated under 21 CFR 886.5844 and reviewed by the Ophthalmic panel.
What device class is NJH?
Class I, regulation 21 CFR 886.5844. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NJH?
Across 2 cleared submissions the average was 81 days from receipt to decision (median 81).
Which companies have the most NJH clearances?
Cantor & Nissel , Ltd. (1); Golden Dental Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NJH
- Run a recall and safety report across every NJH manufacturer
- Watch product code NJH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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