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510(k) Data Aggregation

    K Number
    K210847
    Device Name
    UltraClear Fractional Laser System
    Date Cleared
    2021-12-10

    (263 days)

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

    FA International, LP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UltraClear Laser System is intended for use in Dermatology and Plastic Surgery applications for the following indications for use: General skin resurfacing procedures. Ultra mode is further indicated for the following fractional applications: Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).
    Device Description
    UltraClear Laser System is a transportable device. The system includes the 15" touch screen, on/off switch, foot peddle, an emergency stop button, remote interlock, and calibration port. The device console houses most of the power consuming components, including the laser module, medical grade power supply, the scanner drivers, software, TEC cooling module, water pump, fans, software controls, and all other electrical control components. The laser system is a fiber laser device operating at a wavelength of 2,910nm. The system incorporates a fiber couple laser diode assembly pumping erbium doped fluoride glass fiber to generate laser emission. The laser energy is delivered during treatment via the handpiece. A 635 nm visible red laser diode aiming beam is used to visualize the location of the beam during laser treatment.
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