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510(k) Data Aggregation

    K Number
    K170366
    Device Name
    Laser Peripherals, LLC Family of Bare Laser Fibers
    Manufacturer
    Laser Peripherals, LLC
    Date Cleared
    2017-06-08

    (122 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Laser Peripherals, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laser Peripherals Laser Fiber is indicated for use in all surgical specialties in which compatible laser systems with operational wavelengths between 500nm – 2200nm have received regulatory clearance. Laser Peripherals surgical fiber optic laser delivery devices are intended for use with any cleared surgical laser with an SMA 905 connector, SMA 906 connector, or manufacturer specific connectors and adaptors.
    Device Description
    The Family of 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 open, laparoscopic ablation, coagulation, incision, and excision or vaporizing in any soft/hard-tissue application for which compatible lasers are applicable. The key components of this system are the SMA-905, SMA-906 and Manufacturer's specific connectors and the Fiber Optic. The fiber optic in the laser fiber is the main component in the assembly and is what allows for delivering the energy to the patient. The fiber portion of the laser fiber is comprised of several different materials; these can be thought of as: 1) the fiber core, 2) fiber cladding and coating layers, and 3) the outside coating or the jacket. All fibers featured in this submission have a core consisting of a silica (glass) material. The core is the main light pipe which offers a path for the light energy. The fiber cladding and coating layers are placed over the core and shield the fiber from losing energy over the length of the fiber and guide the energy to exit the distal tip. The material of the cladding and coating layer has a different index of refraction, which directs the light back into the core. This is typically another layer of silica, but may include a chemical layer (e.g., Fluoropolymer). Fiber selection is based on the ability to transmit the light wavelength that the laser is producing. The outside of the laser fiber is coated with a flexible material to offer abrasion and breakage resistance. This coating is typically an ETFE, but some models offer a Polyimide coating for superior resistance. The distal tip of the laser fiber offers the user an opportunity to configure the output energy to suit the needs of the application. The most predominate distal tip configuration is a flat, polished surface. The flat end face of the fiber allows the energy to exit the fiber unaltered. Other configurations manage the light in different ways. This allows the user to use the fiber where a different method of treatment is appropriate. Fibers can be divided into two categories: Contact and Non-contact. This refers to whether the distal tip is touching the subject matter at the worksite or whether it is held back, away from the target. Contact fibers are generally shaped into configurations intended to maximize the effectiveness of the procedure. These shapes include cone tips, ball tips, spherical tips, etc. A third type of distal tip offers further treatment of the laser energy as it exits the fiber. These distal tips utilize added components to either direct the laser light (i.e., ScatterFree™ (SideFire)) or lens the light (focus or dispersed).
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    K Number
    K011207
    Device Name
    LASER PERIPHERALS REUSABLE HOLMIUM FIBER
    Manufacturer
    LASER PERIPHERALS, LLC.
    Date Cleared
    2001-07-24

    (96 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    LASER PERIPHERALS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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