K233564 is an FDA 510(k) clearance for the FLUOBEAM® LX Imaging System (FB-LX). 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 December 15, 2023, 39 days after receiving the submission on November 6, 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 | K233564 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2023 |
| Decision Date | December 15, 2023 |
| Days to Decision | 39 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. |