K190891 is an FDA 510(k) clearance for the Fluobeam LX. This device is classified as a Parathyroid Autofluorescence Imaging Device (Class II - Special Controls, product code QDG).
Submitted by Fluoptics (Grenoble Cedex 9, FR). The FDA issued a Cleared decision on July 31, 2019, 117 days after receiving the submission on April 5, 2019.
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 | K190891 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 05, 2019 |
| Decision Date | July 31, 2019 |
| Days to Decision | 117 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. |