Device Type ID | 4337 |
Device Name | Fluid, Intraocular |
Regulation Description | Intraocular Fluid. |
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 | 886.4275 [🔎] |
FDA Device Classification | Class 3 Medical Device |
Product Code | LWL |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4337 |
Device | Fluid, Intraocular |
Product Code | LWL |
FDA Device Classification | Class 3 Medical Device |
Regulation Description | Intraocular Fluid. |
CFR Regulation Number | 886.4275 [🔎] |
Device Problems | |
---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
Difficult To Remove | 1 |
Total Device Problems | 5 |