Cleared Special

K233564 - FLUOBEAM® LX Imaging System (FB-LX) (FDA 510(k) Clearance)

Also includes:
FLUOBEAM® LX Red Imaging System (FB-LXR)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233564 · Fluoptics Sas (A Getinge Group Company) · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
39d
Days
Class 2
Risk

K233564 is an FDA 510(k) clearance for the FLUOBEAM® LX Imaging System (FB-LX). Classified as Parathyroid Autofluorescence Imaging Device (product code QDG), Class II - Special Controls.

Submitted by Fluoptics Sas (A Getinge Group Company) (Grenoble, FR). The FDA issued a Cleared decision on December 15, 2023 after a review of 39 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4550 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fluoptics Sas (A Getinge Group Company) devices

Submission Details

510(k) Number K233564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2023
Decision Date December 15, 2023
Days to Decision 39 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 114d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QDG Parathyroid Autofluorescence Imaging Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4550
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Getinge Group
Barb Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.