Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4270](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4270) → LPO — Gases Used Within Eye To Place Pressure On Detached Retina

# LPO · Gases Used Within Eye To Place Pressure On Detached Retina

_Ophthalmic · 21 CFR 886.4270 · Class 3_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LPO

## Overview

- **Product Code:** LPO
- **Device Name:** Gases Used Within Eye To Place Pressure On Detached Retina
- **Regulation:** [21 CFR 886.4270](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4270)
- **Device Class:** 3
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An intraocular gas is a device consisting of a gaseous fluid intended to be introduced into the eye to place pressure on a detached retina.

## Classification Rationale

Class III.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P230012](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LPO/P230012.md) | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | Aug 26, 2024 | APPR |
| [P220030](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LPO/P220030.md) | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | Jul 2, 2024 | APPR |
| [P900067](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LPO/P900067.md) | SULFUR HEXAFLUORIDE | Airgas Therapeutics, LLC | Feb 25, 1993 | APPR |
| [P900066](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LPO/P900066.md) | PERFLUOROPROPANE | Airgas Therapeutics, LLC | Feb 25, 1993 | APPR |

## Top Applicants

- Alcon Research, LLC — 2 clearances
- Airgas Therapeutics, LLC — 2 clearances

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LPO](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/LPO)

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