Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3130](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3130) → QWU — Prosthesis, Eyelid Spacer/Graft, Polymer

# QWU · Prosthesis, Eyelid Spacer/Graft, Polymer

_Ophthalmic · 21 CFR 886.3130 · Class 2_

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

## Overview

- **Product Code:** QWU
- **Device Name:** Prosthesis, Eyelid Spacer/Graft, Polymer
- **Regulation:** [21 CFR 886.3130](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3130)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **Implant:** yes

## Identification

An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K223074](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/QWU/K223074.md) | CorNeat EverPatch | Corneat Vision , Ltd. | Jun 2, 2023 | SESE |

## Top Applicants

- Corneat Vision , Ltd. — 1 clearance

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

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