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510(k) Data Aggregation

    K Number
    K980561
    Device Name
    DERMIUM
    Manufacturer
    PREMIER LASER SYSTEMS, INC.
    Date Cleared
    1998-03-19

    (34 days)

    Product Code
    GEX,FEB
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Scanning device attachment used with the Centauri™ Er:YAG Laser System for use in Dermatology for treatment of soft tissue, including incision, excision, hemostasis, ablation and vaporization of tissue.

    Device Description

    Scanning device attachment used with the Centauri™ Er:YAG Laser System

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for the dERmium Scanner for the Centauri™ Er:YAG Laser System II. This document primarily focuses on the regulatory clearance for marketing the device based on substantial equivalence to a predicate device. It defines the intended use and regulatory classification.

    However, the document does not contain any information regarding specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

    Therefore, I cannot provide a detailed answer to your request in the format you specified. The information you are seeking about acceptance criteria and the study that proves the device meets them is not present in the provided text.

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