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The device is intended for endovascular coagulation of blood vessels. Th indicated for the endovascular coagulation of the Greater Saphenous Vein of the thigh in patients with superficial vein reflux.

The ELVeS kit with 2 Ring Radial Fibers contain the following components: (1) 2 ring radial fiber; (2) access needle; (3) introducer sheath/ dilator; and (4) a guidewire and is identical to that cleared under K101712 and K112299 except for the 2 ring radial tip design. The design provides 2 adjacent points of radial emission.

The Twister™ Side-Fire Fiber Optic Delivery System is a delivery accessory used to deliver optical energy and is indicated for use in general surgical applications in combination with any SMA-compatible laser system also indicated for the same applications. It is indicated for use in hemostasis, ablation and vaporization of soft or fibrous tissue in any surgical discipline in contact or non-contact mode with a compatible laser marketed for the desired application. The system can be used with or without a standard viewing scope. It can be inserted through the working channel of a cystoscope, urethroscope, or any other viewing scope.

The Biolitec SIA Twister™ Side-Fire Fiber Optic Delivery System contains identical components and identical patient contact materials as the cleared Biolitec Medical Devices, Inc. Twister™ Side Fire Fiber Optic Delivery System. Twister is a fiber optic delivery system designed to deliver optical energy from a surgical laser to soft or fibrous tissue for the indicated uses. The distal end of the Twister possesses a slight bend at the capillary tip, producing 30° lateral firing which is identical to the predicate. The fiber makeup remains silica, silica cladding, hard plastic cladding, and Tefzel jacketing as is the predicate. The numerical aperture (NA) of the fiber however is 0.26/ 0.37 (whereas the predicate is 0.22/ 0.37) giving a better coupling efficiency and correcting for the truncation in power transmission seen with the predicate fiber when using larger NA lasers.