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510(k) Data Aggregation

    K Number
    K974586
    Device Name
    AURORA DIODE LASER SYSTEM
    Manufacturer
    PREMIER LASER SYSTEMS, INC.
    Date Cleared
    1998-07-15

    (218 days)

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

    AURORA DIODE LASER SYSTEM

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

    (SULCULAR DEBRIDEMENT) - REMOVAL OF DISEASED OR INFLAMED SOFT TISSUE IN THE PERIODONTAL POCKET. NOTE: This is an additional indication to the indications cleared for market release in 510(k) 954316.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but there is no information in the provided document about the acceptance criteria and study proving the device meets them. The document is an FDA 510(k) clearance letter for the Aurora Diode Laser System, indicating it is substantially equivalent to previously marketed devices for the stated indications for use (sulcular debridement). It does not contain details about specific performance metrics, study designs, sample sizes, or expert qualifications.

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