Cleared Traditional

Fluobeam LX (K190891) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190891 · Fluoptics · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2019
Decision
117d
Days
Class 2
Risk

K190891 is an FDA 510(k) clearance for the Fluobeam LX. Classified as Parathyroid Autofluorescence Imaging Device (product code QDG), Class II - Special Controls.

Submitted by Fluoptics (Grenoble Cedex 9, FR). The FDA issued a Cleared decision on July 31, 2019 after a review of 117 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Fluoptics devices

Submission Details

510(k) Number K190891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2019
Decision Date July 31, 2019
Days to Decision 117 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 115d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Daniel & Daniel Consulting, LLC
Michael A. Daniel

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.

Regulatory Peers - QDG Parathyroid Autofluorescence Imaging Device

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