K250455 is an FDA 510(k) clearance for the FLUOBEAM LX Imaging System (FBLX). This device is classified as a Parathyroid Autofluorescence Imaging Device (Class II - Special Controls, product code QDG).
Submitted by Fluoptics Sas (A Getinge Group Company) (Grenoble, FR). The FDA issued a Cleared decision on April 17, 2025, 58 days after receiving the submission on February 18, 2025.
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 | K250455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2025 |
| Decision Date | April 17, 2025 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| 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. |