Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart D — Prosthetic Devices](/submissions/OP/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 886.3320](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3320) → NFM — Expander, Tissue, Orbital

# NFM · Expander, Tissue, Orbital

_Ophthalmic · 21 CFR 886.3320 · Class 2_

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

## Overview

- **Product Code:** NFM
- **Device Name:** Expander, Tissue, Orbital
- **Regulation:** [21 CFR 886.3320](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/886.3320)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **Implant:** yes

## Identification

An eye sphere implant is a device intended to be implanted in the eyeball to occupy space following the removal of the contents of the eyeball with the sclera left intact.

## Classification Rationale

Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is an ocular peg which is supplied sterile only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K060151](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NFM/K060151.md) | ORBITAL TISSUE EXPANDER (OTE) | Innovia, LLC | Aug 8, 2006 | SESE |
| [K010852](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/NFM/K010852.md) | OSMED TISSUE EXPANDER | Iop, Inc. | Aug 13, 2001 | SESE |

## Top Applicants

- Innovia, LLC — 1 clearance
- Iop, Inc. — 1 clearance

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

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