Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System

DEN170092 is the FDA 510(k) clearance record for Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System, a class II device, cleared for Fluoptics on 2018-11-02 under FDA product code QDG (Parathyroid Autofluorescence Imaging Device). FDA's definition for product code QDG reads: "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". FDA records list 3 510(k) clearances for Fluoptics, from 2014-05-07 to 2019-07-31. As of 2026-09-10, FDA records show no recalls naming DEN170092.