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510(k) Data Aggregation

    K Number
    K254197

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-11

    (78 days)

    Product Code
    Regulation Number
    878.4810
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Picasso Pro Diode Laser is indicated for dentistry and oral soft tissue procedures of:

    1. The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissue including abscess treatment, contouring, curettage, sulcular debridement, pulp extirpation, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue.

    2. Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions;

    3. Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.

    Device Description

    The Picasso Pro Diode Laser is a device for delivering laser energy to human oral and dental soft tissue for a variety of surgical procedures and treatments. This energy is generated by solid-state diodes, which provide a consistent and reliable generation of laser energy at 810 ± 20nm for a maximum of 7 watts of energy output. The laser energy is delivered to the surgical site by means of an optical fiber system, which allows for the safe transmission of laser energy to the site without creating undue risk to the patient or operatory staff by errant or collateral laser emissions. The device features some user definable settings, including a switchable 630nm aiming beam, adjustable power output for both the working beam and aiming beam, and continuous delivery or pulse delivery options. The working end of the delivery fiber is contained within a metal handpiece with an attached disposable single-use tip for surgical procedures. This handpiece system is incorporated into the device. The activation of the working beam diodes is completed by use of a foot-actuated switch.

    AI/ML Overview

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