Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5844](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5844) → NJH — Lens, Spectacle (Prescription), For Reading Discomfort

# NJH · Lens, Spectacle (Prescription), For Reading Discomfort

_Ophthalmic · 21 CFR 886.5844 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NJH

## Overview

- **Product Code:** NJH
- **Device Name:** Lens, Spectacle (Prescription), For Reading Discomfort
- **Regulation:** [21 CFR 886.5844](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5844)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K022373](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NJH/K022373.md) | CHROMAGEN V3.0 READING AID & COLOR DISCRIMINATION ENHANCEMENT SPECTACLE LENS | Cantor & Nissel , Ltd. | Oct 7, 2002 | SESE |
| [K853758](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NJH/K853758.md) | PY-RITE | Golden Dental Products, Inc. | Dec 3, 1985 | SESE |

## Top Applicants

- Cantor & Nissel , Ltd. — 1 clearance
- Golden Dental Products, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NJH](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NJH)

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