FLUOBEAM® LX Red

FDA 510(k) K230898 · Fluoptics Sas

Substantially Equivalent

510(k) numberK230898

Submission

Device name
FLUOBEAM® LX Red
Applicant
Fluoptics Sas
Grenoble, FR
Received
March 31, 2023
Decision date
July 28, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QDG – Parathyroid Autofluorescence Imaging Device
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4550
Specialty
General, Plastic Surgery

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.

Other 510(k)s with product code QDG

510(k)DeviceApplicantDecision
K253303Dendrite Imaging SystemQDG · Traditional Dendrite Imaging, Inc.11/28/2025SE
K250455FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)QDG · Traditional Fluoptics Sas (A Getinge Group Company}04/17/2025SE
K233564FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)QDG · Special Fluoptics Sas (A Getinge Group Company)12/15/2023SE
K190891Fluobeam LXQDG · Traditional Fluoptics07/31/2019SE

More from Fluoptics

510(k)DeviceDecision
K190891Fluobeam LXQDG · Traditional 07/31/2019SE
K132475Fluobeam 800 Clinic Laser Imaging Device and Fluocase 800 Control SystemOWN · Traditional 05/07/2014SE

Questions and answers

When was FLUOBEAM® LX Red cleared by the FDA?

FLUOBEAM® LX Red (K230898) received a 510(k) decision of Substantially Equivalent on July 28, 2023, 119 days after the submission was received.

What is the product code of K230898?

The FDA product code is QDG – Parathyroid Autofluorescence Imaging Device, a Class II (moderate risk) device regulated under 21 CFR 878.4550.