Device Type ID | 4429 |
Device Name | Lens, Contact (polymethylmethacrylate) |
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 | 510(k) |
FDA Device Classification | Class Unclassified Medical Device |
Product Code | HPX |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4429 |
Device | Lens, Contact (polymethylmethacrylate) |
Product Code | HPX |
Device Problems | |
---|---|
Contact Lens | 1 |
No Apparent Adverse Event | 1 |
Total Device Problems | 2 |