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The Optical Integrity General Shaped Fibers with LaserGuard™ are intended to be used as an accessory to a medical laser. For specific applications, refer to the Instructions for Use documentation supplied with the laser system being used with the LaserGuard™ system.

The product submitted herein is, in fact, the predicate device fitted with a LaserGuard™ device as an accessory. The basic device is a wave guide for laser light sources and will transmit light between 532 and 2100 nanometer wavelengths. The cladding of the fibers is either doped silica or a polymer. The outer buffer material is either Nylon or Tefzel. The LASERGUARD™ accessory included with the submitted product is an electronic device that will detect heat generated as a result of the fiber overheating anywhere along the light path and will disengage the foot switch of the laser thereby putting the laser in standby mode. The LASERGUARD™ will also indicate by an audible alarm and a light that the fiber has overheated. Both the predicate device and the submitted products are capable of delivering laser radiation from a laser instrument to the surgical site with minimal loss. Both deliver wavelengths from 532 to 2100 nanometers as, for example, is generated by Ho:YAG or Nd:YAG lasers. The laser energy is emitted through a flat, orbed or conical tip located at the distal end of the fiber. Both the predicate and submitted products are offered in a range of core sizes from 145 to 940 micrometer silica cores and are from 2.5 to 5.0 meters in length. The products are supplied in sterile and non-sterile as well as single-use and re-usable versions.

The Optical Integrity General Shaped Fiber is intended to be used for vaporization, cutting, ablation and coagulation of soft tissue in conjunction with or without endoscopic equipment including laparoscopes, hysteroscopes, arthroscopes, cystoscopes, cystoscopes, gastroscopes, and colonoscopes, or for contact or non-contact surgery with or without handpieces for use in coagulation, incision/excision, ablation and vaporization of soft tissue. The Optical Integrity GS Fiber is indicated for use in medicine and surgery in the following specialties: Urology, Plastic Surgery, Radiology, Dermatology, Pulmonology, Gastroenterology, Gynecology, ENT, General and Vascular Surgery, Lithotripsy, Arthroscopy, Podiatry, Orthopedics and Neurosurgery.

The Optical Integrity General Shaped (GS) Fiber is a fiber optic laser delivery system consisting of a 3 meter long silica fiber, clad in fluorinated doped silica, buffered with a fluorinated acrylate and a shaped tip. As an integral part of a laser system, the GS fiber may be used for a wide variety of surgical procedures.