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510(k) Data Aggregation

    K Number
    K170073
    Device Name
    LightMed Dental Laser System
    Date Cleared
    2017-07-25

    (197 days)

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

    LIGHTMED DENTALTECHNOLOGY CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in max!Ilofacial and cosmetic dentistry. It is intended for the incision, excision, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone). The LightMed Dental Laser System is indicated for the following oral and maxillofacial surgery and dentistry: - · Hard Tissue Indications of Erbium Laser Energy: - * Caries removal - * Cavity preparation - * Enamel etching - * Excavation of pits and fissures for placement of sealant - · Bone Indications of Erbium Laser Energy: - * 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) - * Osteotomy - * Osseous crown lengthening - · Soft Tissue and Periodontal Indications of Erbium Laser Energy: - * Excisional and incisional biopsies - * Exposure of unerupted teeth - * Incision and drainage of abscesses - * Gingival incision and excision - * Gingivonlasties - * Gingivectomies - * Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias - * 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, 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
    Device Description
    LightMed Dental Laser System is an erbium: yttrium aluminium garnet (Er: YAG) solid-state laser that provides optical energy at 2940 nm. LightMed Dental Laser System is a delicate integrate device of optical, mechanic, electronic, water and gas, which is consists of a control panel, system controller, laser applicator, power supplies and discharger, laser cooling module, spray water module, footswitch and external remote interlock connector. The laser console is embedded in the laser handpiece, delivers laser energy to the treatment site through a laser tip attached to a handpiece. The laser is activated by means of a footswitch. Various laser tips are available for different clinical applications. The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in maxillofacial and cosmetic dentistry. It is intended for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).
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