Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5925](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5925) → NIC — Lens, Contact, For Reading Discomfort

# NIC · Lens, Contact, For Reading Discomfort

_Ophthalmic · 21 CFR 886.5925 · Class 2_

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

## Overview

- **Product Code:** NIC
- **Device Name:** Lens, Contact, For Reading Discomfort
- **Regulation:** [21 CFR 886.5925](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5925)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.

## Classification Rationale

(1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K012132](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/NIC/K012132.md) | CHROMAGEN V3.0 READING AID SOFT CONTACT LENS | Cantor & Nissel , Ltd. | May 9, 2002 | SESE |

## Top Applicants

- Cantor & Nissel , Ltd. — 1 clearance

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

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