Parathyroid Autofluorescence Imaging Device
General, Plastic Surgery · 21 CFR 878.4550
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.
Recent MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
6 clearances for this product code
- Dendrite Imaging, Inc.Nov 28, 2025
K253303 · Dendrite Imaging System
- Fluoptics Sas (A Getinge Group Company}Apr 17, 2025
K250455 · FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)
- Fluoptics Sas (A Getinge Group Company)Dec 15, 2023
K233564 · FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)
- Fluoptics SasJul 28, 2023
K230898 · FLUOBEAM® LX Red
- FluopticsJul 31, 2019
K190891 · Fluobeam LX
- FluopticsNov 2, 2018
DEN170092 · Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System