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510(k) Data Aggregation

    K Number
    K093048
    Device Name
    D-STORM 810NM, D-STORM 980NM
    Manufacturer
    Date Cleared
    2010-03-23

    (174 days)

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

    LIGHT INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The D-Storm system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry. The D-Storm diode laser system is indicated for: - Incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry - Light activation of bleaching materials for teeth whitening The D-Storm specific indications include the following: Marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and draining of abscesses, tissue retraction, for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers, leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
    Device Description
    The D-STORM Diode Laser is an advanced microprocessor-controlled laser system, composed of the following units: - Control panel; . - . Diode laser - Safe System Control . - . Cooling System - A hand-piece and foot panel; .
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    K Number
    K073411
    Device Name
    LITEDUO
    Manufacturer
    Date Cleared
    2008-05-13

    (161 days)

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

    LIGHT INSTRUMENTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LiteDuo Dental Laser System is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry. The LiteDuo Dental Laser System is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. In addition, the system is intended for light activation of bleaching materials for teeth whitening. This includes the following: Er:YAG Laser: Hard Tissue Indications of Erbium Laser Energy: Caries removal, Cavity preparation, Enamel etching, Enameloplasty, excavation of pits and fissures for placement of sealant, Bone Indications of Erbium Laser Energy: Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue (bone), Apicoectomy - amputation of the root end, Cutting bone to prepare a window access to the apex (apices) of the root(s), Osseoplasty, Osteotomy, Osseous crown lengthening Soft Tissue and Periodontal Indications of Erbium Laser Energy: Excisional and incisional biopsies, Exposure of unerupted teeth, Incision drainage of abscesses, Gingival incision and excision, and a Gingivoplasties, Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias, Gingival troughing for crown impressions. Hemostasis. Implant recovery. Frenectomies and frenotomies, Fibromatosis (fibroma removal), Benign and malignant lesion removal, Operculectomy, Oral papillectomies, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Preprosthetic surgery: flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papillomas, fibromatoses benign growths, Vestibuloplasty, Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Endodontal Indications of Erbium Laser Energy: Tooth preparation to obtain access to root canal, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Pulp extirpation, Root canal debridement and cleaning, Root canal preparation including enlargement. Diode Laser: Marginal and interdental gingiva and epithelial lining of free gingiva, frenectomy frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gigngivioplasty, gingival troughing crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incision and draining of tissue retraction, for impressions, papillectomy, abscesses. vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, removal of hyperplastic tissues, treatment of aphtous ulcers. leukoplakia, sulcular debridement (removal of diseased or inflamed soft tissue, in the periodontal pocket), pulpotomy, pulpotomy as adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.
    Device Description
    The LITEDUO Dental Laser is an advanced microprocessor-controlled laser system, composed of the following units: - . The control panel; - . The Er: Y AG and Diode laser applicators; - High-voltage power supply, capacitor bank and switching module; - . Diode driver and Diode laser array; - The cooling system; - An Er: YAG laser energy verification module.
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