Definition: An Autofluorescence Detection Device For General Surgery And Dermatological Use Is An Adjunct Tool That Uses Autofluorescence To Detect Tissues Or Structures. This Device Is Not Intended To Provide A Diagnosis.
| Device Type ID | 5909 |
| Device Name | Parathyroid Autofluorescence Detection Device |
| Physical State | The Device Has A Patient Contacting Fiber Optic Probe Connected To A Console With A Coherent Excitation Light Source In The Near Infrared Spectrum. The Device Is Used To Capture Autofluorescence Signals Of The Target Tissues. Imaging Contrast Agents |
| Technical Method | The Device Is A Patient Contacting Device That Quantifies The Ratio Of Autofluorescence Of Parathyroid To Thyroid Tissue Using A Coherent Excitation Light Source In The Near Infrared Spectrum. |
| Target Area | Parathyroid Glands. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4550 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QDF |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |