Not Cleared Direct

Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (DEN170092) - FDA 510(k) Clearance

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

DEN170092 · Fluoptics · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
315d
Days
Class 2
Risk

DEN170092 is an FDA 510(k) submission (not cleared) for the Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System. Classified as Parathyroid Autofluorescence Imaging Device (product code QDG), Class II - Special Controls.

Submitted by Fluoptics (Grenoble Cedex 9, FR). The FDA issued a Not Cleared (DENG) decision on November 2, 2018 after a review of 315 days.

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. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 315 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Fluoptics devices

Submission Details

510(k) Number DEN170092 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received December 22, 2017
Decision Date November 02, 2018
Days to Decision 315 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
200d slower than avg
Panel avg: 115d · This submission: 315d
Pathway characteristics

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 Peers - QDG Parathyroid Autofluorescence Imaging Device

Devices cleared under the same product code (QDG) and FDA review panel - the closest regulatory comparables to DEN170092.
Dendrite Imaging System
K253303 · Dendrite Imaging, Inc. · Nov 2025
FLUOBEAM LX Imaging System (FBLX)
K250455 · Fluoptics Sas (A Getinge Group Company) · Apr 2025
FLUOBEAM® LX Imaging System (FB-LX)
K233564 · Fluoptics Sas (A Getinge Group Company) · Dec 2023
FLUOBEAM® LX Red
K230898 · Fluoptics Sas · Jul 2023
Fluobeam LX
K190891 · Fluoptics · Jul 2019