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510(k) Data Aggregation

    K Number
    K031125
    Device Name
    CYNOSURE SMART FILE ND:YAG LASERS
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2003-10-09

    (183 days)

    Product Code
    GEX
    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 Smart File laser device is to provide the ability to perform intraoral soft tissue, general, and oral maxillo-facial surgery. The device is intended for ablation, incision, vaporization and coagulation of soft tissue using a contact, fiber optic delivery system. The device will be used in the folowing areas: general dentistry, otolaryngology, dermatology and plastic surgery.

    Device Description

    Smart File is a Nd:YAG laser, having a Nd:YAG crystal rod as the lasing medium. It is a laser with a wavelength of 1,064 nm. Laser activation is by footswitch. Overall weight of the laser is 38 Kg, and the size is 68x23x65 cm (HxWxD). Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.

    AI/ML Overview

    The provided text is a 510(k) Summary for the Cynosure Smart File, Smart File 6, and Smarty A10 medical laser systems. It explicitly states in the "Nonclinical Performance Data" and "Clinical Performance Data" sections that there is "none".

    Therefore, no acceptance criteria, study details, sample sizes, expert qualifications, or ground truth information related to device performance are present in the provided document. The device was found substantially equivalent based on its comparison to predicate devices in terms of indications for use, principle of operation, wavelength, and pulse energy range, rather than through clinical or nonclinical performance studies detailed in this summary.

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