Definition: Intended In The Detection Of Melanoma And High Grade Lesions Among Atypical Lesions In Order To Rule-out Melanoma.
| Device Type ID | 5960 |
| Device Name | Optical Diagnostic Device For Melanoma Detection |
| Physical State | Optical Radiation. |
| Technical Method | Use Of Visible And Infrared Optical Radiation To Generate Images Of Targeted Atypical Lesions. |
| Target Area | Atypical Pigmented Lesions |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OYD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5960 |
| Device | Optical Diagnostic Device For Melanoma Detection |
| Product Code | OYD |
| FDA Device Classification | Class 3 Medical Device |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | MELA Sciences, Inc. | II | May-20-2015 |