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510(k) Data Aggregation

    K Number
    K031488
    Device Name
    CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER
    Manufacturer
    CYNOSURE, INC.
    Date Cleared
    2003-06-04

    (23 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 APOGEE-TKS II DERMATOLOGICAL LASER

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

    The Cynosure Apogee-TKS II laser is indicated for permanent hair reduction and the treatment of vascular lesions, pigmented lesions and wrinkles.

    The Cynosure Apogee-TKS II Dermatological Laser is indicated for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. It is used for all skin types (Fitzpatrick I - VI) including tanned skin.

    It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.

    Device Description

    Cynosure Apogee-TKS II laser, having an Alexandrite crystal rod as the lasing medium. It is a laser with a wavelength of 755nm.

    Laser activation is by either finger or foot switch. Overall weight of the laser is 45 Kg, and the size is 113x53x84 cm (HxWxD).

    Electrical requirement is 230 VAC, 50A, 50-60 Hz, single phase.

    AI/ML Overview

    The provided 510(k) summary for the Cynosure Apogee-TKS II Laser does not contain any information about acceptance criteria or a study proving the device meets them.

    Instead, the submission states:

    • Clinical Performance Data: none
    • Nonclinical Performance Data: none

    This indicates that the device was cleared based on its substantial equivalence to a predicate device (Cynosure Apogee-TKS) without new clinical or non-clinical performance studies being submitted or required. Therefore, I cannot provide the requested information.

    The FDA's letter further confirms this by stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

    In summary, the provided document does not contain the study details, acceptance criteria, or performance data typically associated with a new device demonstrating efficacy and safety through clinical or non-clinical trials.

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