← Product Code [NCK](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NCK) · K001326

# NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON (K001326)

_Ocular Concepts, LLC · NCK · Jun 13, 2000 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NCK/K001326

## Device Facts

- **Applicant:** Ocular Concepts, LLC
- **Product Code:** [NCK](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NCK.md)
- **Decision Date:** Jun 13, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.3200
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NCK/K001326](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NCK/K001326)

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