LPO · Gases Used Within Eye To Place Pressure On Detached Retina
Ophthalmic · 21 CFR 886.4270 · Class 3
Overview
| Product Code | LPO |
|---|---|
| Device Name | Gases Used Within Eye To Place Pressure On Detached Retina |
| Regulation | 21 CFR 886.4270 |
| Device Class | Class 3 |
| Review Panel | Ophthalmic |
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.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P230012 | 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 | 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 | SULFUR HEXAFLUORIDE | Airgas Therapeutics, LLC | Feb 25, 1993 | APPR |
| P900066 | PERFLUOROPROPANE | Airgas Therapeutics, LLC | Feb 25, 1993 | APPR |
Top Applicants
- Alcon Research, LLC — 2 clearances
- Airgas Therapeutics, LLC — 2 clearances
