Definition: Artificial Iris Is Intended To Be Implanted To Replace The Natural Iris Of The Eye.
Device Type ID | 4454 |
Device Name | Artificial Iris |
Physical State | An Artificial Iris Is Manufactured From A Polymeric Material And May Contain Color Additives To Mimic The Appearance Of The Natural Iris. |
Technical Method | The Artificial Iris Reduces The Light Sensitivity And/or Glare Associated With Aniridia Through The Artificial Pupil At The Center Of The Prosthesis. The Artificial Iris Does Not Include Optical Power For The Correction Of Refractive Errors. |
Target Area | Eye |
Review Panel | Ophthalmic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | QBT |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4454 |
Device | Artificial Iris |
Product Code | QBT |
FDA Device Classification | Class 3 Medical Device |