Gases Used Within Eye To Place Pressure On Detached Retina
Basic Information
- Device Name
- Gases Used Within Eye To Place Pressure On Detached Retina
- Trade Name
- UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery Sy
- PMA Number
- P230012
- Device Class
- FDA Class 3
- Product Code
- LPO
- Generic Name
- Gases used within eye to place pressure on detached retina
- Regulation Number
- 886.4270
- Medical Specialty
- Ophthalmic
- Advisory Committee
- Ophthalmic
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 26, 2024
- Date Received
- March 21, 2023
- Expedited Review
- N
Advisory Committee Statement
Approval for UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System and UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System. The UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System is indicated for intraocular injection into the eye for the treatment of uncomplicated retinal detachments. Associated measures used include vitrectomy, fluid/air exchange, transconjunctival and transscleral cryotherapy, laser photocoagulation, and air/gas exchange.The UNIPURE SF6 Ophthalmic Gas in the UNIPEXY Gas Delivery System is indicated for intraocular injection into the eye for the treatment of uncomplicated retinal detachments. Associated measures used include vitrectomy, fluid/air exchange, transconjunctival and transscleral cryotherapy, and laser photocoagulation.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LPO | Gases Used Within Eye To Place Pressure On Detached Retina | FDA class 3 | Ophthalmic |