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510(k) Data Aggregation

    K Number
    K233803
    Device Name
    UltraClear Laser System (N/A)
    Date Cleared
    2024-05-08

    (161 days)

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

    Acclaro Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UltraClear Fractional Laser System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), benign pigmented lesions, and vascular dyschromia. Fractional Effects: The UltraClear Fractional Laser System with its accessories when used in Ultra mode is intended to produce fractional effects during skin resurfacing.
    Device Description
    UltraClear Fractional 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 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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