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510(k) Data Aggregation

    K Number
    K072868
    Device Name
    ACCOLADE II LASER
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2007-11-05

    (27 days)

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

    ACCOLADE II LASER

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

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA to Cynosure, Inc. regarding the 510(k) premarket notification for their Cynosure Accolade II Laser. This document does not contain any information about acceptance criteria or the study that proves the device meets those criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, nor can I provide the detailed information about sample sizes, ground truth establishment, or multi-reader studies that you've requested.

    The letter focuses on:

    • Confirming the substantial equivalence determination.
    • Listing relevant regulations and responsibilities for the manufacturer.
    • Providing contact information for various FDA offices.

    To answer your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a clinical study report that details the device's performance, testing methods, and acceptance criteria.

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