Product code LPO
- Device name
- Gases Used Within Eye To Place Pressure On Detached Retina
- Medical specialty
- Ophthalmic
- Device class
- 3
- Regulation number
- 886.4270
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P900066S017 | ISPAN Perfluoropropane C3F8 Gas | Airgas Therapeutics, LLC | 2026-04-30 |
| P230012S010 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | 2026-02-17 |
| P220030S010 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | 2026-02-17 |
| P230012S008 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System | Alcon Research, LLC | 2026-02-10 |
| P220030S008 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System | Alcon Research, LLC | 2026-02-10 |
| P230012S009 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | 2026-01-08 |
| P220030S009 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | 2026-01-08 |
| P230012S006 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | 2025-04-30 |
| P220030S006 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | 2025-04-30 |
| P230012S005 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | 2025-03-24 |
| P220030S005 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | 2025-03-24 |
| P230012S004 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | 2025-02-14 |
| P220030S004 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | 2025-02-14 |
| P230012S003 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | 2024-12-13 |
| P220030S003 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | 2024-12-13 |
| P230012S002 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | 2024-12-02 |
| P220030S002 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | 2024-12-02 |
| P230012S001 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | 2024-10-22 |
| P220030S001 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | 2024-10-22 |
| P230012 | UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy | Alcon Research, LLC | 2024-08-26 |
| P220030 | UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery | Alcon Research, LLC | 2024-07-02 |
| P900066S014 | ISPAN Perfluoropropane C3F8 Gas | Airgas Therapeutics, LLC | 2022-08-04 |
| P900066S015 | ISPAN Perfluoropropane C3F8 Gas | Airgas Therapeutics, LLC | 2022-02-02 |
| P900066S013 | ISPAN PERFLUOROPROPANE C3F8 GAS | Airgas Therapeutics, LLC | 2021-09-28 |
| P900067S007 | ISPAN SULFUR HEXAFLUORIDE SF6 GAS | Airgas Therapeutics, LLC | 2012-01-20 |
| P900066S011 | ISPAN PERFLUOROPROPANE C3F8 GAS | Airgas Therapeutics, LLC | 2012-01-05 |
| P900066S010 | ISPAN PERFLUOROPROPANE C3F8 GAS | Airgas Therapeutics, LLC | 2010-08-18 |
| P900067S006 | ISPAN SULFUR HEXAFLUORIDE SF6 GAS | Airgas Therapeutics, LLC | 2010-01-13 |
| P900066S009 | ISPAN PERFLUOROPROPANE C3F8 GAS | Airgas Therapeutics, LLC | 2010-01-13 |
| P900066S008 | ISPAN PERFLUOROPROPANE C3F8 | Airgas Therapeutics, LLC | 2009-02-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10819601025711 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 10819601025704 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 00819601025660 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 00819601025677 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 00819601025684 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 00819601025691 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 00819601025707 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 00819601025714 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 10819601025667 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 10819601025674 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 10819601025681 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 10819601025698 | BVI Medical | Airgas Therapeutics, LLC | 2025-05-20 |
| 10380657530691 | UNIPURE & UNIPEXY | Alcon Laboratories, Inc. | 2024-10-28 |
| 10380657530684 | UNIPURE & UNIPEXY | Alcon Laboratories, Inc. | 2024-10-28 |
| 10380657530677 | UNIPURE & UNIFEYE | Alcon Laboratories, Inc. | 2024-10-28 |
| 10380657530660 | UNIPURE & UNIFEYE | Alcon Laboratories, Inc. | 2024-10-28 |
| 00380657530694 | UNIPURE & UNIPEXY | Alcon Laboratories, Inc. | 2024-10-28 |
| 00380657530687 | UNIPURE & UNIPEXY | Alcon Laboratories, Inc. | 2024-10-28 |
| 00380657530670 | UNIPURE & UNIFEYE | Alcon Laboratories, Inc. | 2024-10-28 |
| 00380657530663 | UNIPURE & UNIFEYE | Alcon Laboratories, Inc. | 2024-10-28 |
| 00885556653418 | R3 | Smith & Nephew, Inc. | 2016-07-19 |
| 00885556653395 | R3 | Smith & Nephew, Inc. | 2016-07-19 |
| 00885556653401 | R3 | Smith & Nephew, Inc. | 2016-07-19 |
| 00885556653388 | R3 | Smith & Nephew, Inc. | 2016-07-19 |
| 00885556653371 | R3 | Smith & Nephew, Inc. | 2016-07-19 |
| 00885556653425 | R3 | Smith & Nephew, Inc. | 2016-07-19 |
| 10860113000116 | ISPAN SF6 Intraocular Gas | ESCALON MEDICAL CORP. | 2014-11-05 |
| 10860113000109 | ISPAN C3F8 Intraocular Gas | ESCALON MEDICAL CORP. | 2014-11-05 |
| 00380657970018 | ISPAN | Alcon Laboratories, Inc. | 2014-09-24 |
| 00380657970025 | ISPAN | Alcon Laboratories, Inc. | 2014-09-24 |