Search Results

Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use OmniGuide PRIMA Surgical Laser fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters

Omni-Guide Holding, Inc. OmniGuide Prima Surgical Laser Fibers are individually packed sterile devices indicated to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are intended for use in laser surgical procedures including, but not limited to open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. Product description, length, laser wavelength compatibility can be found in Section 15 of this 510(k) Premarket Notification. The key components of this system are the SMA-905, SMA-906 with RFID and Manufacturer's specific RFID connectors and the Fiber Optic, these fibers may be used in a variety of laser-based surgical cases. Per [807.92(a)(4)].

Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers are indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. Omni-Guide Holdings, Inc. single-use LISA Laser Surgical Fibers devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adapters.

Omni-Guide Holding, Inc. LISA Laser Surgical Fibers are individually packed sterile devices to provide high quality surgical laser fiber optic delivery systems for laser surgery. The Fibers are for use in laser surgical procedures, including open, laparoscopic, or endoscopic ablation, coagulation, incision, and excision or vaporizing, in soft/hard-tissue application for which compatible surgical lasers are applicable. The key components are the fiber optic, and either an SMA-905, SMA-906, or manufacturer's specific connector. The fibers allow energy to be delivered to the surgical site through the use of glass fiber optic cable. Propagation of the light energy through the glass provides users the ability to direct the energy to the appropriate areas in the body. The Omni Guide Surgical Holding, Inc. single-use LISA Laser Surgical Fibers family of fibers are marketed to physicians as a sterile device within a typical Tyvek/poly pouch. Internally, the fiber is either secured in a wound circle with a Tyvek band, backer-card, or placed in a polyethylene tubing hoop to allow ease of removal. The construction of the fibers is dependent of the application to which it's marketed. There are two main methods of attaching the connector : crimp and adhesive. The crimp offers a reliable connection that will not be affected by heat whereas the epoxy allows a lower cost alternative where high temperatures are not an issue. All fibers offer various connector nuts, heat shrinks, abrasion jackets, strain reliefs or caps that best serve the environment where they are utilized.