Device Type ID | 4445 |
Device Name | Electrosurgical, Radio Frequency, Refractive Correction |
Review Panel | Ophthalmic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | MWD |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4445 |
Device | Electrosurgical, Radio Frequency, Refractive Correction |
Product Code | MWD |
FDA Device Classification | Class 3 Medical Device |