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510(k) K250455

FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) by Fluoptics Sas (A Getinge Group Company} — Product Code QDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2025
Date Received
February 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.

Other clearances for product code QDG

  • K253303 — Dendrite Imaging System (November 28, 2025)
  • K233564 — FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) (December 15, 2023)
  • K230898 — FLUOBEAM® LX Red (July 28, 2023)
  • K190891 — Fluobeam LX (July 31, 2019)
  • DEN170092 — Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (November 2, 2018)