K230898 is an FDA 510(k) clearance for the FLUOBEAM® LX Red. This device is classified as a Parathyroid Autofluorescence Imaging Device (Class II - Special Controls, product code QDG).
Submitted by Fluoptics Sas (Grenoble, FR). The FDA issued a Cleared decision on July 28, 2023, 119 days after receiving the submission on March 31, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4550. 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..
| 510(k) Number | K230898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2023 |
| Decision Date | July 28, 2023 |
| Days to Decision | 119 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QDG - Parathyroid Autofluorescence Imaging Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4550 |
| 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. |