Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3200](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3200) → NCK — Button, Iris, Eye, Artificial

# NCK · Button, Iris, Eye, Artificial

_Ophthalmic · 21 CFR 886.3200 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NCK

## Overview

- **Product Code:** NCK
- **Device Name:** Button, Iris, Eye, Artificial
- **Regulation:** [21 CFR 886.3200](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3200)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.

## 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, if the device is made from the same materials, has the same chemical composition, and uses the same manufacturing processes as currently legally marketed devices.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K001326](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NCK/K001326.md) | NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON | Ocular Concepts, LLC | Jun 13, 2000 | SESE |

## Top Applicants

- Ocular Concepts, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NCK](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NCK)

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