Cleared Special

K230898 - FLUOBEAM® LX Red (FDA 510(k) Clearance)

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

K230898 · Fluoptics Sas · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2023
Decision
119d
Days
Class 2
Risk

K230898 is an FDA 510(k) clearance for the FLUOBEAM® LX Red. Classified as Parathyroid Autofluorescence Imaging Device (product code QDG), Class II - Special Controls.

Submitted by Fluoptics Sas (Grenoble, FR). The FDA issued a Cleared decision on July 28, 2023 after a review of 119 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. 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. Standard predicate reliance. 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 devices

Submission Details

510(k) Number K230898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2023
Decision Date July 28, 2023
Days to Decision 119 days
Submission Type Special
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
5d slower than avg
Panel avg: 114d · This submission: 119d
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

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