FDA applicant

Fluoptics Sas (A Getinge Group Company)

Grenoble, FR2 decisions2023–20250 recalls

FDA records 2 decisions for Fluoptics Sas (A Getinge Group Company) (Grenoble, FR) from 2023 to 2025: 2 510(k) clearances. All are in product code QDG (Parathyroid Autofluorescence Imaging Device). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Fluoptics Sas (A Getinge Group Company}”.

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 Sas (A Getinge Group Company)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Fluoptics Sas (A Getinge Group Company) by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Other applicant names beginning “Fluoptics”

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

Fluoptics 4

Fluoptics Sas (A Getinge Group Company)

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Fluoptics”