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510(k) Data Aggregation

    K Number
    K133425
    Device Name
    SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
    Manufacturer
    ENGINEERED MEDICAL SOLUTIONS CO. LLC.
    Date Cleared
    2013-12-05

    (27 days)

    Product Code
    FTD, FDT
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scintillant Surgical Lights are intended to provide localized illumination of surgical sites.
    Device Description
    The Scintillant Dual Tip Light is a sterile, single-use device designed to provide surgeons with localized brilliant white illumination of the surgical site. Utilizing an internal battery, the device is designed to stay operational for up to three hours of continuous use. Dual light tips in combination with flexible leads containing memory wire allows for the surgeon to direct light from multiple locations optimizing the illumination provided by the device and allowing for increased visibility within the surgical site.
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    K Number
    K130513
    Device Name
    VOLISTA 400; VOLISTA 600
    Manufacturer
    MAQUET SAS
    Date Cleared
    2013-05-08

    (70 days)

    Product Code
    FTD, FSY
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAQUET TRIOP VOLISTA surgical lights are intended to be used to provide visible illumination of the surgical area or the patient during surgical operations, diagnostics and treatment.
    Device Description
    MAQUET TRIOP VOLISTA® Surgical Light Systems have been developed in order to provide any operating room with LED technology. An innovative design combined with a functional shape offers an efficient product to the surgical staff. The TRIOP VOLISTA® Surgical Lights are well-suited for installation in surgical suites, examining rooms, doctor's surgeries and external consultations. The TRIOP VOLISTA® product family is composed by two different lightheads, Volista 400 and Volista 600. The System is available on ceiling versions and may be composed by one, two or three lightheads, which can be every possible combination of VOLISTA 400 and VOLISTA 600. Accessories such as integrated cameras and screen supports can be included to the TRIOP VOLISTA® Surgical Light System.
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    K Number
    K123776
    Device Name
    POLARIS 100/200
    Manufacturer
    DRAGER MEDICAL GMBH
    Date Cleared
    2013-03-08

    (88 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polaris 100/200 lights are classified as operating lights in accordance with IEC 60601-2-41 and are intended to be used for the local illumination of the surgery and treatment area on the patient in operating and treatment rooms. Double light The combination of two operating lights as an operating light system enables the use in operating and treatment rooms. Versions - Polaris 100 light - Polaris 200 light
    Device Description
    The Polaris 100/200 light is designed for use in as an operating light. For the Polaris 100/200 light, LED bulbs are used. The Polaris 100 light combines the illumination intensity of 48 white LED bulbs, the Polaris 200 light combines the illumination intensity of 66 white LED bulbs to form a homogeneous illumination volume of considerable illumination depth and low shadiness. A color temperature similar to natural light with good color rendering and dimmable illumination intensity ensure working conditions for surgical and treatment procedures.
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    K Number
    K111020
    Device Name
    ATRICURE DISSECTOR
    Manufacturer
    ATRICURE, INC.
    Date Cleared
    2011-06-09

    (58 days)

    Product Code
    FTD, GDI
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AtriCure Dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.
    Device Description
    The AtriCure Dissector™ is a hand held, single use, surgical articulated dissector with intearal light source intended to for use by qualified surgeons only. The surgeon is able to articulate the distal member of the device by means of hand actuated rotation knob. The surgeon directly controls the amount of articulation and tissue dissection. A small light source is attached to the distal tip of the articulation member, which remains illuminated for a minimum of four (4) hours. Multiple models of the Dissector™ are available with varving shaft lengths to accommodate surgeon preference and differing patient habitus.
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    K Number
    K100234
    Device Name
    HM-LAMP II
    Manufacturer
    HILLUSA, INC.
    Date Cleared
    2010-07-08

    (163 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HM-LAMP II is a device intended to be used to provide visible illumination of the surgical/field or the patient. They are designed for minor surgical procedures.
    Device Description
    The HM-LAMP II Series are operating lamps with high performance. Flexible movement arm and mobile stand. Designed for minor surgical procedures as well as additional operating room needs.
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    K Number
    K100884
    Device Name
    STRYKER KNIFELIGHT
    Manufacturer
    HOWMEDICA OSTEONICS CORP.
    Date Cleared
    2010-06-25

    (87 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stryker Knifelight is a manual surgical instrument used for the release of the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site which allows for a minimally open technique with minimal disturbance of surrounding tissue.
    Device Description
    The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The device is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the device has integral protective retractors which provide for additional protection of the surrounding tissue during surgery. The Knifelight consists of two integrated components: a handpiece that acts as a power source that is connected to a blade assembly. They are sold as one device.
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    K Number
    K071180
    Device Name
    SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
    Manufacturer
    ENGINEERED MEDICAL SOLUTIONS CO. LLC
    Date Cleared
    2007-06-20

    (51 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Scintillant light is intended to provide localized illumination of surgical sites. The Scintillant Surgical Light is intended to provide localized illumination of surgical sites.
    Device Description
    The Scintillant Surgical Light is an untethered, self-contained medical lighting device that allows illumination inside the surgical field. The light can be hand-held and is provided with accessories which allow it to be attached to almost any surgical tool or instrument. The light is provided sterile and is battery powered. The light consists of light-emitting diode (LED) mounted on the end of a flexible wand. A single button turns the light on and off. A battery and circuit board are contained in the device handle.
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    K Number
    K053364
    Device Name
    HALUX IRIS EXAMINATION AND SURGICAL LAMP
    Manufacturer
    WALDMANN LIGHTING
    Date Cleared
    2006-02-23

    (83 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Halux® Iris is designed to provide the required illumination for surgeries, procedures, and examinations of patients. The Halux® Iris Examination and Surgical Lamp is to be used with various mounting configurations in operating rooms, examination rooms, emergency rooms and all other health care facilities where the need for additional illumination exists.
    Device Description
    Whether in the doctor's office, examination rooms, emergency facilities, intensive care clinics, pre- or post-operative rooms, the Iris provides high intensity light where it is needed. The Iris is user friendly. With its high quality illumination, the halux® Iris is perfect for lighting all kinds of examinations and treatments. Outstanding features of this luminaire include the unique shape of the lamp housing, the combination facetted and parabolic technology of its reflector, and its smooth operating and spring-loaded articulating arm. Highlights of our examination lamp: Smooth Operation and adjustability Precise positioning Compact and enclosed articulation system with counterbalance system. A specially designed reflector system insures a precise light source that renders true colors. The Iris is available in ceiling wall and floor versions. halux® Iris is a medical product manufactured in accordance with EG 93/42 Class 1 and is constructed in accordance with EN 60 601-2-41 (UL2601).
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    K Number
    K041681
    Device Name
    ATRICURE DISSECTOR
    Manufacturer
    ATRICURE, INC.
    Date Cleared
    2004-07-01

    (10 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AtriCure dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.
    Device Description
    The AtriCure dissector™ is a hand held, single use, surgical articulated dissector with integral light source.
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    K Number
    K013242
    Device Name
    AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM
    Manufacturer
    STERIS Corporation
    Date Cleared
    2001-12-13

    (76 days)

    Product Code
    FTD
    Regulation Number
    878.4580
    Why did this record match?
    Product Code :

    FTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff.
    Device Description
    The Amsco Harmony Surgical Lighting and Media System is a family of variable pattern, variable intensity surgical lights designed to provide visible illumination of the surgical field or the patient and to provide audio-visual procedural support for the O.R. staff. The system consists of a center-mounted lighthead suspension, which supports horizontal arms of possible differing lengths and lighthead assemblies and operates via an electronic control system. Optional features for the system include a fiber optic light for task lighting, voice control of the system via the HERMES system, a camera integrated in surgical lighthead, optional standard or flat screen monitor or a high end audio visual system. The system components can be arrayed to produce various system configurations depending upon the needs of the user. The Amsco Harmony Surgical Lighting and Media System has a sterile disposable sheath for postioning of the sterile field during surgical procedures. The sterile sheath is latex free and is made of approved medical grade material. The Amsco Harmony Surgical Lighting and Media System is designed to assure compilance with IEC 60601-2-41 (Ed.1.0 (2000-02) Medical Electrical Equipment - Part 2-41: Particular Requirements for the Safety of Surgical Luminaires and Luminaires for Diagnosis, IEC 60601-1 (Electrical Safety US, Canada). The device carries the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings.
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