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510(k) Data Aggregation

    K Number
    K980559
    Device Name
    PEGASUS ND:YAG LASER SYSTEM
    Manufacturer
    PREMIER LASER SYSTEMS, INC.
    Date Cleared
    1998-08-24

    (192 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K905082
    Why did this record match?
    Device Name :

    PEGASUS ND:YAG LASER SYSTEM

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

    Pulpotomy
    Pulpotomy as an adjunct to root canal therapy

    Device Description

    Pegasus Nd: YAG Laser System

    AI/ML Overview

    This document is a 510(k) clearance letter for the Pegasus Nd:YAG Laser System. It does not contain information about acceptance criteria or a study proving device performance.

    Therefore, I cannot provide the requested information. The letter only states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed for the specified indications for use. It does not include performance data, the details of any studies, or how ground truth was established for such studies.

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