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510(k) Data Aggregation

    K Number
    K041721
    Device Name
    LVI AESTHETIC LASER
    Manufacturer
    HOYA PHOTONICS, INC.
    Date Cleared
    2004-08-05

    (42 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K041721
    Why did this record match?
    Device Name :

    LVI AESTHETIC LASER

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

    For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.
    Examples:
    Excisional and incisional biopsies
    Exposure of unerupted teeth
    Fibroma removal
    Frenectomy and frenotomy
    Gingival troughing for crown impressions
    Gingivectomy
    Gingivoplasty
    Gingival incision and excision
    Hemostasis
    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
    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)
    Treatment of aphthous ulcers
    Vestibuloplasty
    Biopsy incision and excision
    Lesion (tumor) removal

    For light activation for bleaching materials for teeth whitening
    For laser-assisted bleaching/whitening for teeth.

    Device Description

    Dental diode laser

    AI/ML Overview

    The provided 510(k) summary for the LVI lase dental diode laser states that no clinical or non-clinical performance data was submitted.

    Therefore, the device's acceptance criteria and the study proving it meets these criteria are not detailed in the provided text. The submission was likely based on demonstrating substantial equivalence to predicate devices, focusing on operating parameters, physical characteristics, and intended uses rather than novel performance claims requiring extensive new testing.

    The document explicitly states:

    • Nonclinical Performance Data: None
    • Clinical Performance Data: None

    Without specific studies mentioned, it's impossible to provide the requested details regarding:

    1. A table of acceptance criteria and reported device performance
    2. Sample size used for the test set and data provenance
    3. Number of experts used to establish ground truth
    4. Adjudication method
    5. MRMC comparative effectiveness study results
    6. Standalone performance
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established
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