510(k) Report

FDA applicant

Fluoptics

Grenoble Cedex 9, FR4 decisions2014–20230 recalls

FDA records 4 decisions for Fluoptics (Grenoble Cedex 9, FR) from 2014 to 2023: 3 510(k) clearances and 1 De Novo grant. Most are in product codes QDG (Parathyroid Autofluorescence Imaging Device) and OWN (Confocal Optical Imaging). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Fluoptics Sas”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Fluoptics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014: 12018: 12019: 12023: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Fluoptics by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Fluoptics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QDGParathyroid Autofluorescence Imaging Device3decisions
  • OWNConfocal Optical Imaging1decision

Who builds on its devices?

Later devices cite its devices 7 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K190891Fluobeam LXFluoptics · 20193cite it
  • K132475Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control SystemFluoptics · 20142cite it
  • DEN170092Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control SystemFluoptics · 20181cites it
  • K230898FLUOBEAM® LX RedFluoptics Sas · 20231cites it

What has FDA decided for it lately?

  • K230898FLUOBEAM® LX RedFluoptics Sas · 2023
  • K190891Fluobeam LXFluoptics · 2019
  • DEN170092Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control SystemFluoptics · 2018
  • K132475Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control SystemFluoptics · 2014

All 3 as Fluoptics →The one decision as Fluoptics Sas →

Other applicant names beginning “Fluoptics”

FDA records each applicant name separately; these may or may not be the same firm.

Fluoptics Sas (A Getinge Group Company) 2