Device Dossier
General/multiple surgical laser system beam guide, single-use
Device Dossier for General/multiple surgical laser system beam guide, single-use (General/multiple surgical laser system beam guide, single-use, Class…
Intended purpose
The single-use surgical fiber is a delivery device that transmits energy from the laser console to the treatment site through the fiber tip. The surgical fiber includes a connector to secure the surgical fiber to the laser console and RFID capability to communicate surgical fiber information to the laser console for display on the console's touch screen. The single use surgical fibers are sterile packed and approximately 3.1m in length. The fiber is sterilized with ethylene oxide. To avoid risks due to infection and injury, fibers should not be used if the packaging has been damaged or the product use-by date has expired. To ensure the safe and proper handling of the fiber, you must read the associated IFU and associated laser system IFU before opening and using the surgical fiber.