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) → NAI — Lens, Prescription, Color Deficiency

# NAI · Lens, Prescription, Color Deficiency

_Ophthalmic · 21 CFR 886.5844 · Class 1_

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

## Overview

- **Product Code:** NAI
- **Device Name:** Lens, Prescription, Color Deficiency
- **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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K984219](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NAI/K984219.md) | COLORMAX COLOR VISION ENHANCEMENT LENSES | Color Vision Technologies, Inc. | Nov 18, 1999 | SESE |

## Top Applicants

- Color Vision Technologies, Inc. — 1 clearance

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

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