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510(k) Data Aggregation

    K Number
    K994427
    Device Name
    CYNOSURE M2 DERMATOLOGY LASER FOR HAIR REMOVAL
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2000-01-18

    (19 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 M2 Laser is indicated for hair removal application.
    The M2 Laser is indicated for hair removal and benign vascular lesion removal applications.

    Device Description

    The M2 Laser is a solid state laser, having the alexandrite crystal as the lasing medium. It is a pulsed laser with an invisible wavelength of 755nm and a non-contact handpiece. Laser activation is both by finger switch and footswitch. Overall weight of the laser is 285lbs, and the size is 44"x 19"x24" (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.

    AI/ML Overview

    The provided text states: "Nonclinical Performance Data: none" and "Clinical Performance Data: none".

    Therefore, no acceptance criteria, study details, or performance data are available in the provided document. The device was cleared based on substantial equivalence to a predicate device, the Cynosure Apogee Laser, without specific performance studies for this particular submission.

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