K250455
- 510(k) number
- K250455
- Device name
- FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
- Applicant
- Fluoptics Sas (A Getinge Group Company} FR
- Product code
- QDG — Parathyroid Autofluorescence Imaging Device
- Decision date
- 2025-04-17
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K250455.pdf
Official FDA record: K250455
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.