510(k) K250455
K250455 is an FDA 510(k) premarket notification submitted by Fluoptics Sas (A Getinge Group Company} for the device "FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)". The FDA issued a decision of Substantially Equivalent on Apr 17, 2025. The device falls under product code QDG (Parathyroid Autofluorescence Imaging Device), a Class II device regulated under 21 CFR 878.4550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 17, 2025
- Date Received
- Feb 18, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Parathyroid Autofluorescence Imaging Device
- Device Class
- Class II
- Regulation Number
- 878.4550
- Review Panel
- SU
- Submission Type
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.