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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMD LASERS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMD LASERS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
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