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510(k) Data Aggregation

    K Number
    K022464
    Device Name
    EQUILASE SYSTEM
    Manufacturer
    Date Cleared
    2002-11-21

    (118 days)

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

    EQUILASERS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Equilase system, used together with a FDA cleared fiber optic delivery system, is intended for general surgical incision/excision, vaporization, ablation and coagulation of soft tissues. All soft tissues such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands, are included.
    Device Description
    The Equilase System consists of 6 major subsystems: 1. A laser head, where laser radiation is generated from flashlamp excitement of a laser rod in a laser resonator, and the output is focused to a point. The laser head also houses a visible laser diode (VLD). Its beam is combined with the main laser beam as a aiming light. 2. A power conditioner where the input AC power is converted to electrical energy stored in capacitors for discharge into the flashlamp. 3. A cooling system to remove excess heat from the pump chamber, which is located inside the laser head. 4. A microprocessor based controller that regulates the functions of the laser system, checks status of various sensors. 5. A membrane switch keypad for user interface and provides laser parameters readout. 6. A footswitch for activating laser action.
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