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510(k) Data Aggregation

    K Number
    K233653
    Device Name
    Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)
    Manufacturer
    Peregrine Surgical, LLC
    Date Cleared
    2024-08-05

    (265 days)

    Product Code
    MPA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Peregrine Surgical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Midfield Light Pipe is a disposable microsurgical instrument used to conduct a field of light to the posterior seqment of the eye in order to visualize the internal structures of the eyes during ophthalmic surgery.
    Device Description
    The Midfield Light Pipe will be offered in a 23 gauge (GA), 25GA and 27GA size. Each device consists of an ABS handpiece, 304 stainless steel illumination connector, LDPE EVA jacket material, PMMA illumination fiber, 304 stainless steel needle and a PMMA scleral depressor. The Midfield Light Pipe is an external communicating device, in contact with tissue/bone/dentin for a limited duration (<24 hours). The device will be identical to the existing Peregrine 23GA and 25GA Chandelier Illuminator (K151604), except the illumination fiber used in the Midfield will have a higher numerical aperture (NA). The higher NA of the fiber will allow for a wider light field for improved visibility for the surgeon, without compromising illumination intensity ("brightness"). Peregrine will also provide a scleral depressor for use with the Midfield Light Pipe. Transcleral illumination makes use of the scleral depressor for examination of the vitreous base by manipulating and indenting the sclera while illuminating through the sclera. The scleral depressor is only intended to contact the outer surface of the eye (sclera) for a limited duration (<24 hours). The Midfield Light Pipes are comprised of common materials used in ophthalmic devices. The light pipe is mechanical and contains no electrical components. The Midfield Light Pipes only transmit light energy, they do not control the intensity of the light output - this is controlled by the operating system to which it is attached.
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