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FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)

by Fluoptics Sas (A Getinge Group Company)

510(k) K250455

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250455↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250455 Date17 Apr 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
QDG
Models / Variants
FDA applicant
Fluoptics Sas (A Getinge Group Company}
Device Class
Class II
Regulation
21 CFR Part 878.4550
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Fluobeam LX and LM Imaging Systems are Parathyroid Autofluorescence Imaging Devices, designed to detect parathyroid tissue during surgical procedures. These systems utilise autofluorescence imaging technology to enhance visualisation of parathyroid glands, aiding in precise identification and preservation during minimally invasive surgeries, particularly in general and plastic surgery settings.

These devices are supplied as standalone imaging systems, intended for use in operating rooms or surgical suites. The Fluobeam LX and LM are classified as Class II medical devices under FDA regulations, with FDA 510(k) clearance and MDR compliance in the EU. Both systems are reusable and require proper calibration and maintenance as per manufacturer guidelines. No specific sterility requirements are noted, but adherence to surgical site protocols is essential for optimal performance.

Other devices from Fluoptics Sas (A Getinge Group Company)

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures are the Fluobeam LX and LM Imaging Systems primarily designed to assist with?

    The Fluobeam LX and LM Imaging Systems are specifically designed to assist in surgeries where precise identification and preservation of parathyroid glands are critical. They are particularly useful in minimally invasive surgeries within general and plastic surgery settings, helping surgeons visualize parathyroid tissue using autofluorescence imaging technology.

  • Are the Fluobeam LX and LM Imaging Systems reusable, and what maintenance is required?

    Yes, both the Fluobeam LX and LM Imaging Systems are reusable devices. They require proper calibration and maintenance as outlined in the manufacturer’s guidelines to ensure accurate and reliable performance during surgical procedures. Adherence to these protocols is essential for optimal functionality.

  • How are the Fluobeam LX and LM Imaging Systems supplied, and where are they intended for use?

    The Fluobeam LX and LM Imaging Systems are supplied as standalone imaging systems, meaning they are self-contained units designed for direct use in operating rooms or surgical suites. They are not packaged as single-use items, nor do they require additional sterilization beyond standard surgical site protocols.

  • What regulatory pathways have the Fluobeam LX and LM Imaging Systems undergone, and where are they approved for use?

    The Fluobeam LX and LM Imaging Systems have undergone FDA 510(k) clearance in the United States and comply with the EU’s Medical Device Regulation (MDR). Both systems are classified as Class II devices under FDA regulations, ensuring they meet stringent standards for safety and effectiveness in their intended surgical applications.

  • Are there different models or sizes available for the Fluobeam Imaging Systems, and if so, how do they differ?

    The Fluobeam Imaging Systems include two distinct models: the Fluobeam LX (FBLX) and the Fluobeam LM (FBLM). While the exact technical differences between the models are not detailed in the provided data, the distinction likely lies in specific features or performance characteristics tailored for varying surgical needs. Both are designed for the same core purpose—parathyroid tissue visualization—but may offer different operational capabilities or ergonomic advantages.