Definition: Ophthalmic Femtosecond Laser Intended To Provide Refractive Vision Correction By Modification Of The Shape Of The Cornea
| Device Type ID | 4451 |
| Device Name | Femtosecond Laser System For Refractive Correction |
| Physical State | The Device Consists Of A Laser Console, A Computer With Graphic User Interface, A Beam Delivery System That Positions And Focuses The Laser Beam, Patient Bed, And A Patient Interface System That Flattens The Cornea And Holds The Patient's Eye Still D |
| Technical Method | The Laser Console Generates Femtosecond Laser Pulses. When Focused In Transparent Tissue, These Low Energy Pulses Produce Photodisruption (a Highly Localized Region Of Ionized Plasma) Effects That Occur On An Extremely Short Time Scale And Are Confin |
| Target Area | Cornea Of The Eye. |
| 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 | OTL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4451 |
| Device | Femtosecond Laser System For Refractive Correction |
| Product Code | OTL |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 9 |
Use Of Device Problem | 1 |
Application Program Problem: Parameter Calculation Error | 1 |
Device Operates Differently Than Expected | 1 |
Application Program Problem | 1 |
Output Problem | 1 |
| Total Device Problems | 14 |