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510(k) Data Aggregation

    K Number
    K121570
    Device Name
    AURIGA QI
    Manufacturer
    STARMEDTEC GMBH
    Date Cleared
    2013-01-16

    (232 days)

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

    STARMEDTEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auriga QI laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.
    Device Description
    The Auriga QI is a holmium laser system, which emits laser radiation with a wavelenath of approximately 2,1 um. Optical laser power is transferred via an optical application fiber. The indications are lithotripsy, dissection, ablation, resection and coagulation of tissue. The laser system consists of: laser system including control panel (user interface), foot switch, application fiber.
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    K Number
    K111475
    Device Name
    AURIGA XL
    Manufacturer
    STARMEDTEC GMBH
    Date Cleared
    2011-09-28

    (124 days)

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

    STARMEDTEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Auriga XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery
    Device Description
    The Auriga XL is a holmium laser system, which emits laser radiation with a wavelength of approximately 2.1 um. The laser power transfers an optical application fiber. The indications are lithotripsy, dissection, ablation, resection and coagulation of tissue. The laser system consists of: - laser system including control panel (user interface) - foot switch - application fiber
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    K Number
    K103654
    Device Name
    VELA XL
    Manufacturer
    STARMEDTEC GMBH
    Date Cleared
    2011-04-06

    (112 days)

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

    STARMEDTEC GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The vela® XL laser system including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in medical specialities including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynaecology, ENT, Dermatology, Plastic Surgery and General Surgery.
    Device Description
    The vela® XL is thulium laser system, which emits laser radiation with a wavelength of approximately 1.9 µm. The laser power transfers an optical application fiber. The indications are dissection, ablation, resection and coagulation of tissue. The laser system consists of: - laser system including control panel (user interface) - foot switch - application fiber
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