Definition: It Is Indicated For Use On Cutaneous Lesions With One Or More Clinical Or Historical Characteristics Of Melanoma, When A Dermatologist Chooses To Obtain Additional Information When Considering Biopsy. It Should Not Be Used On Clinically Obvious Melan
| Device Type ID | 5959 |
| Device Name | Electrical Impedance Spectrometer |
| Physical State | Device Is Comprised Of 1) Control Unit: Processes Examination Data And Presents Electrical Impedance Spectra On The Display, Includes Touch Screen For User Interaction, 2) Probe: Holds The Electrode Used For Lesion Evaluation, 3)Probe Cable: Connects |
| Technical Method | It Utilizes Electric Impedance To Characterize Skin Tissue In Real-time. It Consists Of A Control Unit And A Disposable Electrode. |
| Target Area | Cutaneous Lesions |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | ONV |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5959 |
| Device | Electrical Impedance Spectrometer |
| Product Code | ONV |
| FDA Device Classification | Class 3 Medical Device |