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510(k) Data Aggregation

    K Number
    K142372
    Device Name
    Pico Way Laser System
    Manufacturer
    CANDELA CORPATION
    Date Cleared
    2014-10-30

    (66 days)

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

    CANDELA CORPATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PicoWay Laser System is indicated for the following at the specified wavelength: 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow, and orange. 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-V) to treat the following tattoo colors: black, brown, green, blue, and purple.
    Device Description
    The PicoWay Laser System is a solid state laser capable of delivering energy at waveleneths of 1064 nm or 532 nm at short durations of 240-750 picoseconds (ps) at repetition rates up to 5 Hz. The device system is comprised of a system console, an articulated arm, and an attached handpiece. The laser output at each wavelength is generated within the laser chassis and delivered to the skin through an articulated arm delivery system terminated by a zoom handpiece (HP). The light-weight and ergonomic zoom handpiece allows the spot size on the skin to be easily adjusted from 3 mm to 6 mm in steps of 1 mm. The system includes an internal calibration port with an internal meter located on the control panel of the system console, which is used to verify the transmission of the laser beam into the articulated arm. The PicoWay system control panel enables the user to select the desired energy density (fluence) level and repetition rate. The control panel is also used to obtain feedback from the system, such as the number of pulses delivered or spot size selected.
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