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510(k) Data Aggregation

    K Number
    K233398
    Device Name
    Faros Surgical System
    Manufacturer
    Oertli Instrumente AG
    Date Cleared
    2024-06-27

    (268 days)

    Product Code
    HQC, GEI, HQE
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Oertli Instrumente AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation, as well as ancillary functions such as vitreous cutting along with bipolar diathermy. Faros is used for these surgical interventions in the anterior eye segment: - Irrigation and aspiration (I/Afunction) - Ultrasound phaco (PHACO function) - Biopolar diathermy for hemostasis and coaptation of the conjunctiva (DIA function) - Bipolar diathermic capsulotomy (CAPS function) - Operation of a vitrectomy instrument (VIT function) The device may only be used with the instruments recommended and supplied by Oertli.
    Device Description
    The Faros Surgery System is designed for use in anterior segment eye surgery, primarily for removal of cataractous lenses. The system generates high-frequency ultrasound to emulsify the eye's natural lens, which is then aspirated using fluidics. The system also includes functions for bipolar diathermy (for hemostasis, conjunctival coaptation, and capsulotomy), as well as for anterior vitrectomy, a procedure associated with cataract surgery. The Faros Surgery System consists of a main unit (an AC-powered tower-like device with a control panel governing surgical functions, and ports to connect surgical instruments), with a mounted infusion pole and a foot pedal used by the surgeon to control system functions. An irrigation tubing system is mounted onto the main unit. Surgical handpieces connected to the main unit are used to perform irrigation and aspiration, ultrasound phacoemulsification, bipolar diathermy, bipolar diathermic capsulotomy, and anterior vitrectomy functions.
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    K Number
    K133562
    Device Name
    CATARHEX 3
    Manufacturer
    OERTLI INSTRUMENTE AG
    Date Cleared
    2014-08-12

    (265 days)

    Product Code
    HQC, GEI, HQE
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    OERTLI INSTRUMENTE AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CataRhex 3 is used for surgical interventions in the anterior eye segment. - Irrigation and aspiration (I/A function) - Ultrasound phaco (PHACO function) - Bipolar diathermy for hemostasis and welding of the conjunctiva (DIA function) - Diathermic capsulotomy (CAPS function) - . Operation of a vitrectomy instrument (VIT function) The device may only be used with instruments recommended and supplied by Oertli Instrumente AG.
    Device Description
    The CataRhex 3 is medical electrical equipment to be used during eye surgery and is intended for ophthalmic anterior segment surgery. It provides capabilities for phacoemulsification, phacofragmentation, diathermy coagulation, irrigation/ aspiration, vitrectomy and capsulotomy. The equipment has a display and buttons for selecting and activating the functions. With the equipment a footswitch is delivered for control by the surgeon.
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