Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011092264

FEI Number

3011092264

Entity Name

FLUOPTICS SAS

City/State/Country

GRENOBLE Auvergne-Rhone-Alpes, FR

Establishment Address

44 rue des berges, GRENOBLE Auvergne-Rhone-Alpes 38000, FR

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

FLUOPTICS SAS (Owner Number: 10047454)

Owner / Operator Contact Address

44 rue des berges, GRENOBLE, FR-ARA 38000, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190891

PMA Number

N/A

All Registered Proprietary Names

FLUOBEAM LM FLUOBEAM LX FLUOBEAM LX Red FLUOBEAM LX FLUOBEAM LM FluoPod FLUOCLIP Fluobeam 800 Fluocart FLUOBEAM LX FLUOBEAM LM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2025-06-27
QDG	Parathyroid Autofluorescence Imaging Device	General, Plastic Surgery	Class 2	878.4550	2025-06-27
QDG	Parathyroid Autofluorescence Imaging Device	General, Plastic Surgery	Class 2	878.4550	2024-04-19
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2016-12-20
FXR	Holder, Camera, Surgical	General, Plastic Surgery	Class 1	878.4160	2020-02-10
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2014-09-08
BZN	Cart, Emergency, Cardiopulmonary (Excluding Equipment)	Anesthesiology	Class 1	868.6175	2015-06-17
QDG	Parathyroid Autofluorescence Imaging Device	General, Plastic Surgery	Class 2	878.4550	2019-09-02

Official Correspondent

No official correspondent registered.

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

FLUOPTICS SAS

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K260108	Stryker Endoscopy	L12 LED Light Source with AIM	2026-02-12
K191144	Mauna Kea Technologies	Cellvizio 100 Series System with Confocal Miniprobes	2020-01-24
K243591	Optosurgical, LLC	OPTOVISION Endoscopic Light Source Unit	2025-02-19
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20

Similar Registrations

Registration Number	Establishment Name	Location
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
3010177712	FIBERTECH CO., LTD.	Sakura-shi Chiba, JP
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US
3014342096	KARL STORZ SE & CO KG	TUTTLINGEN Baden-Wurttemberg, DE
8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011092264. Last updated year: 2026. Please use registration number 3011092264 when referencing this establishment in official correspondence.