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) → HQH — Eye, Artificial, Non-Custom

# HQH · Eye, Artificial, Non-Custom

_Ophthalmic · 21 CFR 886.3200 · Class 1_

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

## Overview

- **Product Code:** HQH
- **Device Name:** Eye, Artificial, Non-Custom
- **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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K952538](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K952538.md) | ROBERT B. SCOTT PLASTIC ARTIFICAL | Robert B. Scott Ocularists of Florida, Inc. | Jun 26, 1995 | SESE |
| [K945270](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K945270.md) | CUSTOM ARTIFICIAL HUMAN EYES | Daniel T Acosta | May 30, 1995 | SESE |
| [K946226](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K946226.md) | CUSTOM OCULAR PROSTHESIS | Frank Tanaka, Ocularist, Inc. | Mar 22, 1995 | SESE |
| [K923167](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K923167.md) | THE NISSEL ARTIFICIAL EYE | Nissel , Ltd. | Sep 2, 1992 | SESE |
| [K904962](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K904962.md) | EYE ARTIFICIAL CUSTOM | Midwest Eye Laboratories, Inc. | Aug 30, 1991 | SESE |
| [K791923](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQH/K791923.md) | SCLERAL POWDER | Ocularists , Ltd. | Jan 10, 1980 | SESE |

## Top Applicants

- Daniel T Acosta — 1 clearance
- Frank Tanaka, Ocularist, Inc. — 1 clearance
- Midwest Eye Laboratories, Inc. — 1 clearance
- Nissel , Ltd. — 1 clearance
- Ocularists , Ltd. — 1 clearance

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

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