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510(k) Data Aggregation

    K Number
    K992084
    Device Name
    CYNOSURE SURESCAN WITH THE CO3 ER: YAG LASER
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    1999-07-12

    (21 days)

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

    The Cynosure SureScan with the CO3 Er: YAG Laser is used for skin resurfacing, and for the incision, excision, ablation or vaporization of soft bodily tissues. Typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.

    Device Description

    The SureScan with the CO3 Er:YAG Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench.

    AI/ML Overview

    This 510(k) summary for the Cynosure SureScan with the CO3 Er:YAG Laser does not include any acceptance criteria or details of a study proving the device meets said criteria.

    The submission explicitly states:

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

    This device was cleared based on its substantial equivalence to a predicate device (Cynosure CO3 Er:YAG Laser) in terms of treatment wavelength, pulse duration, pulse energy, and biological effects, not on specific performance criteria demonstrated through a study.

    Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets them from the provided text.

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