Device typeGastrointestinal photodynamic therapy laser beam guide: A sterile, hand-held, probe-like device intended to be used in conjunction with an oncological laser system for directing and delivering laser energy to the upper gastrointestinal (GI) tract (e.g., oesophagus, stomach, duodenum) during photodynamic therapy (PDT) for local cancer treatment; it is not intended to be used for other laser applications (e.g., ablation, excision, vaporization). It typically consists of a fibreoptic cable with a distal probe inserted via the oral cavity, and is available in a variety of configurations for each section of the upper GI tract. This is a single-use device.
FDA categorySystem, Laser, Fiber Optic, Photodynamic Therapy
Device ID00376128000247
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Length2.0 Centimeter