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510(k) Data Aggregation

    K Number
    K151101
    Device Name
    Lotus Series 4 Ultrasonic Surgical System & Accessories
    Manufacturer
    SRA DEVELOPMENTS, LTD.
    Date Cleared
    2015-07-17

    (84 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SRA DEVELOPMENTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Lotus Series 4 Ultrasonic Surgical System & Accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. Lotus Series 4 Ultrasonic Surgical System and Accessories may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint)
    Device Description
    The SRA Developments Lotus Series 4 Ultrasonic Surgical System and Accessories consists of 3 main components - the power module which generates the ultrasonic energy and provides overall control of the device, the reusable part of the handset (Transducer and waveguide); and the disposable part of the handset (Handpiece). The Lotus Series 4 Ultrasonic Surgical System and Accessories employs torsional mode ultrasound at 35.8-36.6kHz to cut and coagulate soft tissue during laparoscopic or open surgery.
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    K Number
    K072961
    Device Name
    LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX)
    Manufacturer
    SRA DEVELOPMENTS, LTD.
    Date Cleared
    2007-12-19

    (61 days)

    Product Code
    JDX, SUB
    Regulation Number
    888.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    SRA DEVELOPMENTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX) is indicated for the softening of bone cement to facilitate the removal of implants, including pedicle screws and other spinal implants, during revision surgery.
    Device Description
    The USCIX consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable implant removal handpiece, a reusable acoustic coupler and a range of single use adaptors. USCIX employs longitudinal mode ultrasound at nominally 29kHz (Range 28.00-30.00kHz) to remove cemented implants for revision.
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    K Number
    K063531
    Device Name
    SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM
    Manufacturer
    SRA DEVELOPMENTS, LTD.
    Date Cleared
    2007-02-22

    (92 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SRA DEVELOPMENTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Series 3 LOTUS shear & hook are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. LOTUS may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecological, thoracic surgery, and exposure to orthopedic structures (such as hip joint).
    Device Description
    The SRA Developments Series 3 LOTUS Laparoscopic Ultrasound Surgery System consists of the power module which generates the ultrasonic energy and provides overall control of the device, the reusable part of the handset; and the disposable part of the handset. The Series 3 LOTUS system employs torsional mode ultrasound at 35-40kHz to cut and coagulate soft tissue during laparoscopic or open surgery.
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    K Number
    K032424
    Device Name
    LOTUS
    Manufacturer
    SRA DEVELOPMENTS, LTD.
    Date Cleared
    2003-12-16

    (133 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SRA DEVELOPMENTS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LOTUS Laproscopic Ultrasound Surgery System is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important, LOTUS may be used as an adjunct to or substitute for electrosurgery, laser surgery, and traditional scalpels in general, gynecologic, and thoracic surgery.
    Device Description
    The LOTUS (Laparosopic Operation by Torsional UltraSound) system consists of the power module, the reusable part of the handset, and the disposable part of the handset. The Lotus system employs torsional mode ultrasound at 36 kHz to cut and coagulate soft tissue during laparoscopic or open surgery.
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