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510(k) Data Aggregation
K Number
K062719Device Name
GREENLIGHT HPS SERIES SURGICAL LASER SYSTEM & ACCESSORIES
Manufacturer
LASERSCOPE
Date Cleared
2006-12-01
(80 days)
Product Code
GEX
Regulation Number
878.4810Why 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
K061646Device Name
LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES
Manufacturer
LASERSCOPE
Date Cleared
2006-06-27
(15 days)
Product Code
FBO, KOG
Regulation Number
876.1500Why 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
K034011Device Name
GEMINI SURGICAL LASER SYSTEM & ACCESSORIES
Manufacturer
LASERSCOPE
Date Cleared
2004-03-30
(97 days)
Product Code
GEX
Regulation Number
878.4810Why 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
K024206Device Name
AURA ISURGICAL LASER SYSTEM & ACCESSORIES
Manufacturer
LASERSCOPE
Date Cleared
2003-11-17
(332 days)
Product Code
GEX
Regulation Number
878.4810Why 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
K020021Device Name
LYRA SURGICAL LASER SYSTEM AND ACCESSIORIES (ND:YAG CONFIGURATION)
Manufacturer
LASERSCOPE
Date Cleared
2002-07-02
(180 days)
Product Code
GEX
Regulation Number
878.4810Why 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
K010834Device Name
LYRA SERIES SURGICAL LASER SYSTEM & ACCESSORIES
Manufacturer
LASERSCOPE
Date Cleared
2001-05-21
(62 days)
Product Code
GEX
Regulation Number
878.4810Why 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
K010284Device 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
878.4810Why 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
K003765Device 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
878.4810Why 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
K003147Device 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
878.4810Why 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
K990718Device 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
878.4810Why 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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