| Device Type ID | 4334 |
| Device Name | Gases Used Within Eye To Place Pressure On Detached Retina |
| Regulation Description | Intraocular Gas. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD) |
| Submission Type | PMA |
| CFR Regulation Number | 886.4270 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LPO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4334 |
| Device | Gases Used Within Eye To Place Pressure On Detached Retina |
| Product Code | LPO |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Intraocular Gas. |
| CFR Regulation Number | 886.4270 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 5 |
Gas Delivery System | 4 |
Sticking | 2 |
Delivery System Failure | 2 |
Valve | 1 |
Unexpected Therapeutic Results | 1 |
Device Inoperable | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Regulator | 1 |
No Flow | 1 |
| Total Device Problems | 19 |