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510(k) Data Aggregation

    K Number
    K062719
    Device Name
    GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
    Manufacturer
    LASERSCOPE
    Date Cleared
    2006-12-01

    (80 days)

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

    LASERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GreenLight HPS™ Surgical Laser System and Accessories are intended for the surgical incision/excision, vaporization, ablation and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. 532nm Applications: General Surgery, Gastroenterology, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Neurosurgery, Opthamology, Plastic Surgery, Spinal Surgery, Thoracic Surgery, Urology. 1064nm Applications: Endoscopic/Laparoscopic General Surgery, Gastroenterology, General Surgery, Gynecology, Head and Neck/Otorhinolaryngology (ENT), Hemostasis during Surgery, Neurosurgery, Oculoplastics, Orthopedics, Plastic Surgery, Pulmonary Surgery, Thoracic Surgery, Urology.
    Device Description
    The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems: The Optical and Laser resonator System, The Electronics and Electrical System, Operator Interface, A variety of Delivery Devices and Accessories, A Cooling Sub-system.
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    K Number
    K061646
    Device Name
    LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
    Manufacturer
    LASERSCOPE
    Date Cleared
    2006-06-27

    (15 days)

    Product Code
    FBO, KOG
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    LASERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laserscope GDD Cystourethroscope Hardware System is intended to provide the user with the means for endoscopic diagnostic and therapeutic surgical procedures. Examples of use of the product include the visualization and manipulation of anatomy, ablation, biopsy, incision, and resection of tissue, and/or as the surgeon deems appropriate. The system is intended for use in general urological surgery through minimally invasive approach by utilizing natural orifices to access the surgical site. The system's use is intended for, but not limited to the following types of procedures: Dilation of the urethra and cold slitting strictures Trans-urethral incision, vaporization, and resection of the prostrate Trans-urethral removal of bladder tumors
    Device Description
    The 24 Fr GDD Cystourethroscope is designed with a continuous flow outer sheath, a separate inner sheath/bridge, and an obturator. The outer sheath has the inflow and outflow Stopcocks attached to it. The inner sheath/bridge has one integral accessory port and can accommodate one accessory up to 9 Fr in size. The obturator is designed to allow atromatic introduction of the outer sheath in a natural orfice. The true continuous flow design washes away blood and small tissue particles to ensure a clear operative field. The working length is 23.2 cm to allow access to the entire lower urinary tract. The dedicated operative channel stabilizes accessories including laser fibers. The Continuous Flow Laser Cystourethroscope is designed to be used with low viscosity fluids, including normal saline, Glycine, Sorbitol, or Ringer's Lactate, and standard surgical accessories.
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    K Number
    K034011
    Device Name
    GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
    Manufacturer
    LASERSCOPE
    Date Cleared
    2004-03-30

    (97 days)

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

    LASERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laserscope Gemini™ Laser System & Accessories is indicated for: KTP/532 Applications: Dermatology: To treat moderate inflammatory Acne vulgaris. ND:YAG/1064 Applications: Dermatology: For use in the Dermatological Applications for the treatment of facial wrinkles. It is also intended to effect stable long-term, or permanent hair reduction in skin types I - VI through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term, stable, reduction in the number of hairs re-growing after a treatment regimen.
    Device Description
    The Laserscope Gemini™ Surgical Laser System and Accessories consists of four major subsystems: The Optical and Laser resonator System. The Electronics and Electrical System Operator Interface. A variety of Delivery Devices and Accessories A Cooling Sub-system
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    K Number
    K024206
    Device Name
    AURA ISURGICAL LASER SYSTEM & ACCESSORIES
    Manufacturer
    LASERSCOPE
    Date Cleared
    2003-11-17

    (332 days)

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

    LASERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laserscope Aura i Laser System & Accessories is indicated to treat moderate inflamatory acne vulgaris.
    Device Description
    The Laserscope Aura i Surgical Laser System & Accessories are comprised of the following main components: - A Laser Console - A Fiber Port (for Delivery Devices) - Control and Display Panels - Operating Software - Footswitch and Handswitch Delivery Controls - Accessories - A Cooling Sub-system
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    K Number
    K020021
    Device Name
    LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
    Manufacturer
    LASERSCOPE
    Date Cleared
    2002-07-02

    (180 days)

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

    LASERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laserscope Lyra TM Laser Systems & Accessories are indicated for use in the Dermatological applications for the treatment of facial wrinkles.
    Device Description
    The Lyra™ Series Surgical Laser Systems are Nd: YAG lasers producing laser emission @ 1064nm. The Laserscope Lyra Surgical Laser System consists of four major subsystems: The Optical and Laser Resonator system; The Cooling system; The Electronics and Electrical system; The Operator interface.
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    K Number
    K010834
    Device Name
    LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
    Manufacturer
    LASERSCOPE
    Date Cleared
    2001-05-21

    (62 days)

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

    LASERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K010284
    Device Name
    LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
    Manufacturer
    LASERSCOPE
    Date Cleared
    2001-05-01

    (90 days)

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

    LASERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003765
    Device Name
    LYRA G SERIES SURGICAL LASER SYSTEM (SL SERIES Q-SWITCHED ND:YAG CONFIGURATION)
    Manufacturer
    LASERSCOPE
    Date Cleared
    2001-03-06

    (90 days)

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

    LASERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K003147
    Device Name
    LYRA SERIES SURGICAL LASER SYSTEM (SL SERIES, ND:YAG CONFIGURATION)
    Manufacturer
    LASERSCOPE
    Date Cleared
    2000-12-15

    (66 days)

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

    LASERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990718
    Device Name
    ORION SERIES SURGICAL LASER SYSTEM (SL SERIESQ-SWITCHED ND:YAG CONFIGURATION)
    Manufacturer
    LASERSCOPE
    Date Cleared
    2000-03-08

    (370 days)

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

    LASERSCOPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orion Series Surgical Laser System (Q-Switched Nd:YAG configuration) is intended for the removal and reduction of unwanted hair. The Crion Series Surgical Laser System and the Lyra Surgical Laser System are intended for the lightening and removal of unwanted body hair in Fitzgatrick Skin Ty I to VI using 1064 nm, Nd:YAG.
    Device Description
    The Orion Series Surgical Laser System consists of a movable console containing power supplies, a treatment laser on a solid optical deck, and a cooling system to dissipate the heat generated by the system. A keypad control panel with CRT enables the user to control the laser system operating parameters. Surgical power is controlled via a footswitch. Laser power is emitted only when the footswitch is depressed. The delivery system is through fiber optics.
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