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510(k) Data Aggregation

    K Number
    K102359
    Device Name
    PICASSO/ PICASSO LITE/ PICASSO PERIO
    Manufacturer
    AMD LASERS, LLC
    Date Cleared
    2011-09-16

    (393 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Abbreviated
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PICASSO/ PICASSO LITE/ PICASSO PERIO

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

    The Picasso ™/Picasso Lite™/ Picasso Perio™ is generally indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following:

    • Gingival troughing for crown impression .
    • 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 (curettage, removal of diseased, inflamed and . necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility).
    • Removal of highly inflamed edematous tissue affected by bacteria penetration of . the pocket lining and junctional epithelium.

    Teeth Whitening Indications (Picasso Only):

    • Laser assisted whitening/bleaching of teeth .
    • Light activation for bleaching materials for teeth whitening. .

    New Indication for Use:

    Laser periodontal:

    Picasso assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA for the AMD Lasers Picasso™/Picasso Lite™/Picasso Perio™ device. It primarily concerns the approval of new indications for use for an existing device and does not contain information about acceptance criteria or a study proving the device meets said criteria.

    Therefore, I cannot provide the requested information. This document is a regulatory approval letter, not a study report.

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