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 | 5910 |
| Device Name | Parathyroid Autofluorescence Imaging Device |
| Physical State | The Device Has A Non-contact Image Head That Emits A Coherent Excitation Light In The Near-infrared Spectrum And Captures An Autofluorescence Image Of The Target Tissues. Imaging Contrast Agents Are Not Required For Autofluorescence Imaging. |
| Technical Method | The Imaging Device Is A Non-contact Medical Device That Captures Autofluorescence Images 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 | QDG |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5910 |
| Device | Parathyroid Autofluorescence Imaging Device |
| Product Code | QDG |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 878.4550 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FLUOPTICS | ||
GRANTED | 1 | |