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510(k) Data Aggregation

    K Number
    K974674
    Device Name
    CYNOSURE PHOTOLIGHT FLASHLAMP SYSTEM
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    1998-04-29

    (135 days)

    Product Code
    GEX,GEZ
    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

    The PhotoLight System is indicated for the treatment of benign cutaneous vascular lesions.

    Device Description

    The PhotoLight pulsed light system is a medical device utilizing optical energy for photocoagulation of vascular lesions

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a 510(k) summary and FDA clearance letter for the Cynosure PhotoLight System. It states:

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

    Therefore, I cannot populate the table or answer the questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The FDA found the device "substantially equivalent" to a predicate device (PhotoDerm VL by ESC Medical Systems) based on its intended use and treatment parameters, not on new clinical performance data from the submitter.

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