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510(k) Data Aggregation

    K Number
    K022464
    Device Name
    EQUILASE SYSTEM
    Manufacturer
    EQUILASERS, INC
    Date Cleared
    2002-11-21

    (118 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K990903
    Why did this record match?
    Device Name :

    EQUILASE SYSTEM

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

    The Equilase system, used together with a FDA cleared fiber optic delivery system, is intended for general surgical incision/excision, vaporization, ablation and coagulation of soft tissues. All soft tissues such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands, are included.

    Device Description

    The Equilase System consists of 6 major subsystems:

    1. A laser head, where laser radiation is generated from flashlamp excitement of a laser rod in a laser resonator, and the output is focused to a point. The laser head also houses a visible laser diode (VLD). Its beam is combined with the main laser beam as a aiming light.
    2. A power conditioner where the input AC power is converted to electrical energy stored in capacitors for discharge into the flashlamp.
    3. A cooling system to remove excess heat from the pump chamber, which is located inside the laser head.
    4. A microprocessor based controller that regulates the functions of the laser system, checks status of various sensors.
    5. A membrane switch keypad for user interface and provides laser parameters readout.
    6. A footswitch for activating laser action.
    AI/ML Overview

    The provided text is a 510(k) Premarket Notification Summary for the Equilase System, a surgical Nd:YAG laser. This document describes the device, its intended use, and its technological characteristics in comparison to a predicate device. It does not contain information about acceptance criteria, study methodologies, or performance metrics in the way that would typically be described for a medical imaging or diagnostic device's AI component.

    Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based on the provided text.

    The document essentially states that the Equilase System is "substantially equivalent" to a legally marketed predicate device (Laserscope's Lyra Series Surgical Laser System), focusing on a comparison of their technical specifications rather than clinical performance studies against specific acceptance criteria.

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