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510(k) Data Aggregation

    K Number
    K132975
    Device Name
    SPHINX JR
    Manufacturer
    ALLMED SYSTEMS INC.
    Date Cleared
    2014-03-18

    (176 days)

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

    ALLMED SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sphinx Jr. laser system is intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
    Device Description
    The Sphinx Jr. system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media and non aqueous medium. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece endoscopic surgical instrument or similar approved device. It consists of: Laser Console with Internal Computer Control Panel and Display Operating Software Fiber port Footswitch
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    K Number
    K110941
    Device Name
    REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200
    Manufacturer
    ALLMED SYSTEMS INC.
    Date Cleared
    2013-02-19

    (687 days)

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

    ALLMED SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200 laser systems and their fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery. and Arthroscopy
    Device Description
    The RevoLix Family of diode pump solid state ( that include the RevoLix Jr 30, RevoLix Jr 50, RevoLix 160 and RevoLix 200) are part of a family of surgical laser systems operating at a wavelength of 2.01 micron. The purpose of these lasers is to ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic surgical applications and procedures in an aqueous and non-aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a hand piece. endoscopic or laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
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    K Number
    K070924
    Device Name
    FLEXGUARD
    Manufacturer
    ALLMED SYSTEMS INC.
    Date Cleared
    2007-06-21

    (79 days)

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

    ALLMED SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FlexGuard Family of sheath's are intended for use in surgical procedures using flexible scopes and other approved flexible or rigid fiber optic delivery devices, to protect the working channel from damage when a laser fiber is introduced and also to provide irrigation to the surgical site when used for incision, ablation, vaporization and coagulation of soft tissue with any approved laser with a wavelength from 532nm to 2100nm in medical specialties including: Urology, Gasteroenterology, Thoracic, Head and Neck, Pulmonary, Gynecology, ENT and General Surgery
    Device Description
    The FlexGuard is a family of flexible sheaths that are used to protect the working channel of a flexible scope or surgical device from mechanical damage when the laser fiber is introduced into the working channel. The tip of the FlexGuard is allowed to protrude approx 3mm beyond the laser fiber, this assembly is then inserted into the working channel of the scope. The FlexGuard Family is designed to work with a range of laser fibers from 200 micron to 600 micron diameter. It consists of: Flexible Sheath Fiber clamp/Yee piece
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    K Number
    K070466
    Device Name
    REVOLIX DUO LASER SYSTEM
    Manufacturer
    ALLMED SYSTEMS INC.
    Date Cleared
    2007-04-17

    (60 days)

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

    ALLMED SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revolix Duo continuous wave 2.01 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery. The Revolix Duo pulsed Holmium 2.1 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in use in medical specialties including: Urnlogy, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
    Device Description
    The RevoLix Duo is a combination of a diode pump solid state laser operating at a wavelength of 2.01 micron and a pulsed flashlamp Holmium laser operating at 2.1 microns. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
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    K Number
    K070476
    Device Name
    REVOLIX 120
    Manufacturer
    ALLMED SYSTEMS INC.
    Date Cleared
    2007-03-26

    (34 days)

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

    ALLMED SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revolix 120 laser systems and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy
    Device Description
    The RevoLix 120 laser system is diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
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    K Number
    K051167
    Device Name
    REVOLIX AND REVOLIX JR
    Manufacturer
    ALLMED SYSTEMS INC.
    Date Cleared
    2005-06-01

    (27 days)

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

    ALLMED SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revolix and RevoLix Jr laser systems and its fiber optic delivery system are intended for used in surgical procedures and experience coagulation and hemostasis of soft including excision, resection, abiation, raponiation, valuation, varian and tissue in use in medical specialites inoldung: Orelegy, Central Surgery, General Surgery.and Arthroscopy
    Device Description
    The RevoLix and RevoLix Jr are diode pump solid state surgical laser system operating at a wavelength of 2.01 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery, laparoscopic and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic/laparoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
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    K Number
    K033437
    Device Name
    SPHINX LASER SYSTEMS
    Manufacturer
    ALLMED SYSTEMS INC.
    Date Cleared
    2004-01-20

    (84 days)

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

    ALLMED SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sphinx laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
    Device Description
    The Sphinx system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic surgical instrument. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
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    K Number
    K033423
    Device Name
    REVOLIX LASER SYSTEMS
    Manufacturer
    ALLMED SYSTEMS INC.
    Date Cleared
    2004-01-15

    (80 days)

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

    ALLMED SYSTEMS INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Revolix laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialities including: Urology, Gasteroenterlogy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
    Device Description
    The RevoLix diode pump solid state is a surgical laser system operating at a wavelength of 2.0 micron. The purpose of the laser is the ablation, coagulation, and hemostasis of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via a fiber optic delivery system and this is guided by a handpiece or endoscopic surgical instrument. It consists of Laser Console with Internal Computer Control Panel and Display, A fiber optic delivery system, Footswitch.
    Ask a Question

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