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    K Number
    K091562
    Device Name
    DOCTOR SMILE A-810 AND B-980 LASERS
    Manufacturer
    LAMBDA SCIENTIFIC SPA
    Date Cleared
    2009-09-08

    (103 days)

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

    LAMBDA SCIENTIFIC SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Doctor Smile A-810 Laser is intended for use in the following procedure: Soft Tissue, Laser Periodontal procedures and tooth whitening. Intra- and extra oral surgery including incision, excision, vaporization, ablation, haemostasis and coagulation of oral soft tissues, Laser soft tissue curettage, whitening. Following specific indications: Excisional and incisional biopsies, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivoplasty, Gingival incision and excision Haemostasis and coagulation, Implant recovery, Incision and drainage of abscess Leukoplakia, Operculectorny, Oral papillectornies, Pulpotomy as an adjunct to root canal therary, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty, Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket. Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingiyal index, gingival bleeding index, probe depth, attachment loss and tooth mobility.). Light activation of whitening/bleaching material. Doctor Smile B-980 Laser is intended for use in the following procedure: Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissue in medical specialties including dentistry, gastroenterology, dermatology, general surgery, gynecology, opthamology, pulmonology, otolaryngology, othopedics. Dental applications: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivoplasty, Gingivolasty, Gingival Troughing, Crown Lengthening, Haemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions. Papillectory, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unemupted Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials
    Device Description
    Doctor Smile A-810, B-980 Lasers are the same standard diode medical lasers respectively with 810, 980 nm wavelength. Doctor Smile A-810, B-980 Lasers are portable instruments which transmit laser energy via a contact fiber optic delivery system and each unit is compromised of the following main components: -a laser system console (including display panel, software and control); -a fiber optic delivery system; -one or more handpieces -protective eye ware
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