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510(k) Data Aggregation

    K Number
    K083142
    Device Name
    PICASSO LASER SYSTEM
    Manufacturer
    AMD LASERS, LLC
    Date Cleared
    2009-03-13

    (141 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K030539,K021227,K003385,K003440,K050453,K062071
    Why did this record match?
    Device Name :

    PICASSO LASER SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Picasso" is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:
    · Gingival troughing for crown impressions
    · Gingivectomy
    · Gingivoplasty
    · Gingival incision and excision
    · Hemostasis and coagulation
    · Excisional and incisional biopsies
    · Exposure of unerupted teeth
    · Fibroma removal
    · Frenectomy and frenotomy
    · Implant recovery
    · Incision and drainage of abscess
    · Leukoplakia
    · Operculectomy
    · Oral papillectomies
    · Pulpotomy
    · Pulpotomy as an adjunct to root canal therapy
    · Reduction of gingival hypertrophy
    · Soft tissue crown lengthening
    · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
    · Vestibuloplasty
    Laser periodontal procedures, including:
    · Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss and tooth mobility).
    · Laser soft tissue curettage
    · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket,
    · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
    Tooth Whitening Indications:
    · Laser assisted whitening/bleaching of teeth.
    · Light activation for bleaching materials for teeth whitening.

    Device Description

    The Picasso" is a diode laser with an 810 nm wavelength.

    AI/ML Overview

    The provided text is a 510(k) summary for the Picasso™ diode laser. It explicitly states under section 6, "Performance Data": "None presented."

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because this data is not included in the provided document. The device was cleared based on substantial equivalence to predicate devices, rather than a new performance study demonstrating it meets specific acceptance criteria.

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