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510(k) Data Aggregation

    K Number
    K974633
    Device Name
    SCANTECH LASER SCANNER
    Date Cleared
    1998-01-16

    (35 days)

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

    PHANTOM TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialties including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology including, but not limited to use in oculoplasty. The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation and photo thermolysis of soft tissue in medical specialies including: general surgery, plastic surgery, aesthetic surgery, dermatology, ophthalmology (timited to periobital dermis).
    Device Description
    The Phantom ScanTech handpiece is intended to be used with the Phantom Family of Medical Lasers to deliver a broad spectrum of laser light energy for use in surgical applications generally requiring the ablation, vaporization, excision, incision and coagulation of soft tissue in a variety of medical specialties. The Phantom ScanTech handpiece is composed of the following main components: Handpiece with dual galvo X - Y scanning capabilities Control / power cable Laser control / display panel interface CPU based Laser control system CPU controlled power supply Removable spatula-bayonet tip Screw ring attachment for articulated arm Used in conjunction with the Phantom Family of Medical Lase automated scanning device to accurately and quickly apply computer-controlled patterns of various shapes and sizes. The Physician, or his/her assistant, will select the desired shape, size and density, as well as other operating parameters, from the Phantom laser's interactive touch screen.
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    K Number
    K972915
    Device Name
    ERBIUM 2000 LASER FAMILY
    Date Cleared
    1997-12-19

    (134 days)

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

    PHANTOM TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Erbium 2000 laser family is designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include: general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, opthamology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures.
    Device Description
    Phantom Erbium lasers are composed of the following components: - a laser console . - a counterbalanced articulated arm and handpiece . - a control / display panel ● - a finger trigger or foot petal control ● - ● a laser head w / beam optics - a CPU control system - . a power supply - an internal cooling system Models range from 5 to 50 Watts average power.
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