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510(k) Data Aggregation

    K Number
    K142830
    Device Name
    Ophthalmed Bending Laser Probes
    Manufacturer
    OPHTHALMED LLC
    Date Cleared
    2015-06-25

    (268 days)

    Product Code
    HQF, HQB
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ophthalmed Bending Laser Probes (Models A207000, and A307000) are indicated for performing laser endophotocoagulation in the posterior segment of the eye during vitreoretinal surgery at an operating wavelength range from 500 to 1100 nm.
    Device Description
    This laser probe is made out of 8ft fiberoptic, terminated on one end with Alcon compatible (SMA905) laser connector, and on another side with a handpiece for holding and manipulation during surgery. For protection against damages, a flexible plastic jacket covers the length of the fiber. The handpiece is terminated by a proximal stainless steel tubing that is 20, 23 or 25 gauge in size, and ending with a distal pre-curved PEEK memory tube that can change angle when activated by the sliding button on the handle side. When the sliding button on the handle is advanced, an internal straightening tube advances into the distal pre-curved PEEK memory tube, thus causing a reduction of the angle of the pre-curved PEEK memory tube, down to zero degrees at the maximum sliding position, allowing the selection of the desired angle during surgery. The maximum angle is 55 degrees for 20g and 23g, and 40 degrees for 25g. This device allows to transmit laser energy from the laser source to the surgical site, facilitated by the aiming beam that is provided by the laser source. This device does not provide illumination and should not be used to illuminate the surgical site.
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    K Number
    K050807
    Device Name
    20G SMA LASER FIBER, MODEL LF100
    Manufacturer
    OPHTHALMED LLC
    Date Cleared
    2005-09-21

    (175 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use to perform endo-ocular laser photocoaguation treatments, with illumination, aspiration and back-wash during surgical interventions. The operating wavelength is 500 nm to 1,100 nm.
    Device Description
    This device consists of the following parts already connected to each other: Handpiece with a 20G extension that holds the tip of the fibers and tubes, and guides it inside the eye. 8 ft fiber. A special connector that attaches the laser fiberoptic end to the laser source. A special connector that attaches the illumination fiberoptic end to the illumination source Luer lock that attaches the aspiration/ back-wash tube to the vitrectomy machine A flexible plastic jacket covers the length of the fiberoptics and tubes. Laser fiberoptic provides the function of laser photocoagulation treatment. Illumination fiberoptic (by providing illumination) provides the physician with the view at the surgical site, while aspiration/backwash tube allows suction of intraocular fluids at the surgical site to facilitate the laser photocoagulation.
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    K Number
    K021696
    Device Name
    20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25
    Manufacturer
    OPHTHALMED LLC
    Date Cleared
    2002-08-20

    (90 days)

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

    OPHTHALMED LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THIS DEVICE IS INDICATED FOR USE TO PERFER 1 PHOTOCo.9 GULATION TREATHENTS INSUDE THE EYE LASER ાં. ૮ . PANKETINAL PHOTOCOAGULATION, MACULAR TREATHENTS, ENDO PHOTO COLLIATION TO CILIARY PROCESSES, LASER TRABECUPLASTY ) , DURING SURGEAL INTERVENTIONS e g .: TRANS PARS PLANA VITRECTOry Si4 To 532 nm THE OPERATING WAVELENGTH IS
    Device Description
    This device consists of the following parts already connected to each other: - Handpiece with either a 20G or a 25G extension that holds the tip of the fiber and guides it inside the eye. - 6 ft fiber. - A special connector that attaches the fiber end to the laser source. - A flexible plastic jacket covers the length of the fiber.
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