LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K141403
    Device Name
    LITHO DK30
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Date Cleared
    2014-08-07

    (71 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K091909
    Why did this record match?
    Device Name :

    LITHO DK30

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

    INTENDED USE

    The device Litho DK30 including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.

    INDICATIONS FOR USE

    The device Litho DK30 including a fiber optic delivery system is insurgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to:

    • Urology
    • · Gastroenterology
    • Arthroscopy
    • Neurosurgery
    • Pulmonary
    • Gynecology
    • ENT
    • Dermatology
    • Plastic Surgery
    • General Surgery
    Device Description

    The modified device Litho DK30 is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). This Special 510(k) of the modified device Litho DK30 is submitted due to Device Modifications of the already cleared device Litho (K091909): Litho DK30 is the desktop version of the already cleared device Litho (K09109). Both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um. The device Litho including a fiber optic delivery system is intended to be used in surgical procedures such as open, laparoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for device modifications (Litho DK30) to an already cleared device (Litho). It focuses on demonstrating substantial equivalence to the predicate device due to minor modifications that do not change the fundamental scientific technology or intended use.

    This is a regulatory submission for device modifications, not a study evaluating performance against specific acceptance criteria. The device is a "Laser surgical instrument for use in general and plastic surgery and in dermatology," and the modifications are primarily mechanical, electrical and software changes to create a desktop version of an existing device.

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

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1