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510(k) Data Aggregation

    K Number
    K983950
    Device Name
    CERALAS DIODE LASER SYSTEM (MODEL H)
    Manufacturer
    CERAMOPTEC, INC.
    Date Cleared
    1999-02-03

    (90 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K974346,K973324
    Why did this record match?
    Device Name :

    CERALAS DIODE LASER SYSTEM (MODEL H)

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

    The Ceralas H Laser System is a surgical instrument indicated to treat leg veins in dermatology and plastic surgery procedures. Specific indications for the Ceralas H Laser System include the treatment of leg veins.
    The Ceralas H 808nm Diode Laser System is indicated to treat leg veins in dermatology and plastic surgery procedures.

    Device Description

    The Ceralas H Laser System is a complete, self-contained compact surgical laser that utilizes gallium alumnum arsenide (GaAlAs) semiconductor diodes to generate near-infrared laser radiation. The laser system consists of a console, footswitch, and handpiece which are connected to the device's console. The diode laser is enclosed in a rugged, factory aligned, environmentally protective module. The handpiece is placed against the patient's skin and a pulse of light is delivered to the skin surface when the footswitch and handpiece trigger are depressed.

    The wavelength for the Ceralas H Laser System is 808 ± 20nm. The laser delivers pulsed light with a selectable pulse duration of 5-30 millsseconds and a fluence of 10-40J/cm2. The corresponding pulse energy delivered through the 9x9mm handpiece is 8-32 Joules. The laser pulses are generated at a maximum pulse repetition frequency of up to 1 Hz. Additionally, the software and software development activities are in accordance with FDA's guidance document. "Reviewer Guidance For Computer Controlled Medical Devices Undergoing 510(k) Review."

    AI/ML Overview

    The provided text does NOT describe acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a 510(k) summary for the Ceralas Diode Laser System, which focuses on establishing substantial equivalence to a predicate device (StarLight™ Pulsed Diode Array Laser System) for regulatory clearance.

    Specifically, the "Performance Data" section states: "None required." This indicates that for this particular 510(k) submission, the FDA did not require the applicant to submit performance data from a clinical or human-based study to demonstrate the device's efficacy or safety against specific acceptance criteria. The clearance was based on technological characteristics and a declaration of substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot provide the requested information because it is not present in the given text.

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