LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K962902
    Device Name
    FOTONA SKINLIGHT LASER SYSTEM
    Manufacturer
    MEDICAL LASER SOLUTIONS
    Date Cleared
    1997-01-10

    (169 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K953585
    Why did this record match?
    Device Name :

    FOTONA SKINLIGHT LASER SYSTEM

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

    The laser is intended to be used for cutting, and coagulating soft tissue.

    Device Description

    The Fotona Skinlight system is based on Er: Y AG laser technology. Within the system, an optical cavity contains the Er: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in noncontact mode. The System is capable of emitting up to 1.0 Joule of pulsed light at 2.94 um, with a (nominal ) pulsewidth of 300 us. The Skinlight system is designed with 5 major sub-systems: a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main triggering pulse. b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger. c) An Er:YAG laser rod, capable of generating 1.0 Joule optical pulses at a frequency up to 15 Hz. d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece. e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.

    AI/ML Overview

    The provided text describes a medical device, the Fotona Skinlight system, and argues for its substantial equivalence to a predicate device (Schwartz Electro-Optics TriLase 2940). However, the text does not contain any information about acceptance criteria, device performance metrics, or any study that proves the device meets specific acceptance criteria.

    Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided document.

    The document discusses the laser's physical characteristics, intended use, and its technological similarities to a predicate device to argue for substantial equivalence, which is a regulatory pathway. It does not present clinical trial data or performance studies against predefined acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1