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510(k) K233564

FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) by Fluoptics Sas (A Getinge Group Company) — Product Code QDG

K233564 is an FDA 510(k) premarket notification submitted by Fluoptics Sas (A Getinge Group Company) for the device "FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)". The FDA issued a decision of Substantially Equivalent on Dec 15, 2023. 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
Dec 15, 2023
Date Received
Nov 6, 2023
Clearance Type
Special
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 (Nov 28, 2025)
  • K250455 — FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (Apr 17, 2025)
  • K230898 — FLUOBEAM® LX Red (Jul 28, 2023)
  • K190891 — Fluobeam LX (Jul 31, 2019)
  • DEN170092 — Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (Nov 2, 2018)

FDA data resources