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The VaporMax LDD® family of laser fibers, which includes VaporMAX LDD, Mega/OULE LDD and MoJO LDD, are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500 nm and 2200 nm have received regulatory clearance. The VaporMAX LDD family of laser delivery fibers are intended for use with any cleared surgical laser having a SMA 905 connector or manufacturer specific connectors and adaptors.

VaporMAX LDD® family of fibers, which includes VaporMAX LDD®, MegaJOULE LDD, and MoJo LDD, are fiber optic surgical laser energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905 or Trimedyne OmniPulse™ MAX, an anodized aluminum extension sleeve or polymer overnut for accommodating recessed laser ports, fiber/connector strain relief, and a transmitting optical fiber consisting of a low [OH-], fused silica core fiber with fluorine-doped, fused silica cladding, a fluoropolymer secondary cladding and an ethylene tetrafluorethylene copolymer (ETFE, e.g. DuPont Tefzel 210™) protective jacket. The distal tip is laser polished and is disposed within a fused quartz capsule (cap) containing a beam conditioning lens and a prism for redirecting the output at nearly right angles to the fiber longitudinal axis. The dimensional difference between the optical fiber and the distal cap is equalized with a Udel tube covering the distal length of fiber that may be tasked to pass a cystoscope bridge working channel, sized to match the cap diameter and upon which is dispose a green visual indicator of the fiber rotational orientation. The proximal end of the diameter matching tube is terminated within a patent pending control knob for ergonomic rotational control (aiming). Some models of the VaporMAX LDD, those with subscripted "e", where e" indicates "ergonomic") exploit severing the connection between the redirection prism from the transmitting fiber by providing for free rotation of the cap about the fiber, vial the control knob, thereby aiming the fiber output without torquing the transmitting fiber. VaporMAX LDD fibers are packaged as a coil upon a coated fiberboard or dense polymer carrier card that is intended to provide for ease of dispensing within the surgical field while immobilizing the product within the sterile pouch. The working end (distal section) of the fiber is maintained in a straight configuration to avoid "fiber jumping" when rotated in surgery (due to the device's "memory" of being stored in a coil). Carrier cards are sealed within non-woven/impermeable pouches, e.g., Tyvek/paper or Tyvek/Mylar, currently validated by IQ for a three-year shelf life. Sealed sterile pouches are protected by an outer, nonsterile fiberboard carton. Both the sterile pouch and carton are labeled with the product information per FDA labeling requirements. All tissue contacting VaporMAX LDD materials of construction, and any materials in fluidic communication with tissue, are USP Class VI biocompatible and are compatible with ethylene oxide (EO) sterilization.

ProFlex CO2 Laser Fiber is indicated for the ablation, coagulation, incision, and vaporization of soft tissue in open, endoscopic, and laparoscopic surgical procedures.

ProFlex CO2 Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, a hollow glass tube having a dielectric coating (silver/silver iodide) in the bore and a fluoropolymer outer coating and an ethylene tetrafluoroethylene copolymer (ETFE, Tefzel™) protective jacket. ProFlex CO2 Laser Fibers are packaged in a coiled and tubular, high-density polyethylene (HDPE) carrier providing improved ease of dispensing within the surgical field while maintaining sterility. Coils are contained within non-woven/impermeable polymer, e.g. Tyvek/Mylar, sterile pouches, validated for three-year shelf life, and protected with an outer, nonsterile fiberboard carton. Both sterile pouch and carton are labeled. All ProFlex CO2 Laser Fiber materials of construction are USP Class VI biocompatible and are compatible with ethylene oxide (EtO) sterilization. ProFlex CO2 Laser Fibers are for prescription use only.

ProFlex® Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, hemostasis, excision, resection and incision and of soft and cartilaginous tissues. While designed primarily for holmium (Ho:Y AG) lasers, ProFlex laser fibers may be used with any laser wavelength between 500 nm and 2200 nm that have been cleared for surgical use including, but not limited to frequency doubled Nd: Y AG (KTP) lasers, argon lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.

Subject devices and primary predicate devices are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, doubly step index clad optical fiber (fluoroacrylate over fluorine doped fused silica) with an ethylene tetrafluorethylene (ETFE, Tefzel™) protective jacket and are available in five nominal fiber core diameters (200 um, 273 µm, 365 µm, 550 um, 910 um, and 940 um), three nominal lengths (3 meters, 3.5 meters and 4.25 meters) and two laser-formed working tips (flat and orb). Subject devices and primary predicate devices are equipped with spatial and angular laser launch overfill protection -- a protective and guiding quartz ferrule, fused about the fiber input face upon which an input lens is laser-formed for high laser and physical damage threshold and for collimation of the laser focus energy within the optical fiber - and ruggedized output tips designed for ease of transit in flexible ureteroscopes and stone basket channels. Smaller fibers (where base fiber cores are smaller than laser foci) are equipped with tapered inputs where larger fibers are straight terminations. Subject devices are packaged in a coiled high density polyethylene (HDPE) tube carrier providing ease of dispensing within the surgical field while maintaining sterility. All materials of construction are USP Class VI biocompatible and are compatible with flash autoclave and ethylene oxide (EtO) sterilization.

Proflex™ Laser Fibers are intended for use in laser-based surgical applications including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, ablation, hemostasis, excision, resection and incision and of soft and cartilaginous tissues. While designed primarily for holmium (Ho: YAG) lasers, ProFlex™ fibers may be used with any laser wavelength between 500nm and 2200mm that have been cleared for surgical use including, but not limited to frequency doubled Nd: YAG (KTP) lasers, argon lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.

The ProFlex™ Laser Fibers are fiber optic energy delivery devices consisting of a stainless steel laser connector, e.g. SMA 905, an anodized aluminum expansion nut, strain relief, doubly step index clad optical fiber (fluoroacrylate over fluorine doped fused silica) with an ethylene tetrafluorethylene (ETFE, Tefzel™) protective jacket and are available in two fiber core diameters: 200µm & 273µm. The ProFlex™ Laser Fibers are equipped with laser launch overfill protection (spatial and angular) -- a protective, transmissive quartz ferrule, fused about the fiber input face and laser polished for high damage threshold (laser and physical), and ruggedized output tips designed for ease of transit in flexible ureteroscopes. All materials of construction are USP Class VI biocompatible and compatible with flash autoclave and EtO sterilization.

General SureFlex™ and AccuFlex™ are intended for use in laser-based surgical applications, including but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary) and surgical procedures involving vaporization, abaltion, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue. While designed primarily for holmium (Ho:YAG) lasers, SureFlex™ and AccuFlex™ fibers may be used with any laser wavelength between 500nm and 2200nm that have been cleared for surgical use including, but not limited to frequency doubled Nd: YAG (KTP) lasers, argon lasers, diode lasers, alexandrite lasers, ruby lasers, dye lasers, Nd:YAG lasers and Tm:YAG lasers.

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The InnovaQuartz General Shape Laser Fiber is indicated for use in the vaporization, coagulation, hemostasis and incision of soft tissue. It is designed for use with ND: Yag laser systems, HO: Yag laser systems or Argon laser systems which have been cleared for medical use and accept SMA 905 connectors.

InnovaQuartz General Shape Laser Fiber