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510(k) Data Aggregation

    K Number
    K160549
    Device Name
    MEDICAL DIODE LASER SYSTEMS
    Manufacturer
    WUHAN GIGAA OPTRONICS TECHNOLOGY CO., LTD
    Date Cleared
    2017-04-07

    (403 days)

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

    WUHAN GIGAA OPTRONICS TECHNOLOGY CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "VELASI -15D" is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
    Device Description
    Medical diode laser systems are a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The medical diode laser systems for this unit is GaAlAs diode bar, and the wavelength is 1470nm of VELAS II-15D. It features impact structure, high efficiency and long lifetime. The beam divergence angle is too large lead to poor beam quality. In order to better meet the needs of Laser Diode practical applications, Laser Diode carried beam shaping is very necessary. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. To start the laser unit, turn the main switch ON and turn the key switch clockwise to "I" position. The power indicator will turn green immediately with the system fans working. At the same time, the LCD screen lights up. After the parameters setting is finished, press the "Ready" button and the system will remind you to wear the protective eyewear (protective wavelength is from 800nm to 1700mm). At this time when you press down the footswitch, the laser will emit.
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    K Number
    K151890
    Device Name
    Medical Diode Laser Systems
    Manufacturer
    Wuhan Gigaa Optronics Technology Co., Ltd
    Date Cleared
    2015-12-23

    (166 days)

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

    Wuhan Gigaa Optronics Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The "GBOX-15A/15B" are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), qynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only). The "VELASII-30A/30B" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology (BPH), Genitourinary (UJrology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology Endovascular coagulation, Oral Surgery and Dental procedures, laser assisted lipolysis. The "VELASII -60A/60B/60C" are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue. Such as: Dermatology, Aesthetics, Plastic Surgery, Vascular Surgery, Podiatry, Endovenous Occlusion of the greater saphenous vein of the thigh in patients with superficial vein reflux.
    Device Description
    Medical diode laser systems are a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The medical diode laser systems for this unit is GaAlAs diode bar, and the wavelength are 810mm/980mm of GBOX-15A/15B, 810/980mm of VELAS II -30A/30B, 810/980/940nm of VELAS II -60A/60B/60C. It features impact structure, high efficiency and long lifetime. The beam divergence angle is too large lead to poor beam quality. In order to better meet the needs of Laser Diode practical applications, Laser Diode carried beam shaping is very necessary. With the GIGAA'S unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. To start the laser unit, turn the main switch ON into " | " position. Immediately the power indicator will be green with the system fans working. At the same time, the LCD screen lights up as the picture shows below. After finishing setting the parameters, press the "Ready" button and then the system will remind you to wear the safety goggles (protect wavelength from 800nm to 1100nm). At this time when you press down the footswitch, the laser will emit.
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