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510(k) Data Aggregation

    K Number
    K971737
    Device Name
    CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    1997-08-08

    (88 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 :

    CYNOSURE PHOTOGENICA LPIR DERMATOLOGICAL LASER

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

    The PhotoGenica LPIR laser is indicated for hair reduction.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the CYNOSURE PhotoGenica LPIR Dermatological Laser. While it states the device's intended use for "hair reduction" and mentions its regulatory classification, it does not contain any information about acceptance criteria, specific studies, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the given input. The letter focuses on the FDA's marketing clearance and regulatory compliance, not the technical details of the device's performance studies.

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