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510(k) Data Aggregation

    K Number
    K053139
    Device Name
    FOTONA QX ND:YAG/KTP LASER SYSTEM
    Manufacturer
    FOTONA D.D.
    Date Cleared
    2006-02-16

    (99 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K000317,K014234,K023967
    Predicate For
    K083203,K083889
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Incision, excision, ablation, vaporization of soft tissue for general dermatology.
    2. 532 nm wavelength:
    • removal of light ink (red, tan, purple, and orange) tatoos, "
    • removal of pigmented lesions, removal of vascular lesions,
    • treatment of Lentigines, treatment of Cafe-Au-Lait,
    • treatment of Common Nevi,
    • treatment of Seborrheic Kearotoses,
    • treatment of Post Inflammatory Hyperpigmentation.
    1. 1064 nm wavelength:
    • removal of dark ink (black, blue and brown) tattoos, -
    • treatment of Nevus of Ota, -
    • removal or lightening of unwanted hair, -
    • treatment of Common Nevi. -
    • skin resurfacing with or without adjuvant preparation --
    Device Description

    The Fotona QX laser system is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd: YAG laser beam through a frequency doubling non-linear crystal. The Nd:YAG laser 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 therapeutic and aiming beams are guided by articulated arm to a focusing handpiece. Both lasers are used in non-contact mode. Both laser wavelengths share a common power supply, control system, and cooling system. The internal computer can be directed to select either the Nd: YAG head or the KTP Nd: YAG laser wavelength. When the laser is first turned on the physician is able to select the desired wavelength via control panel. The Fotona QX laser system consists of: 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) The microprocessor based controller, which regulates the functions of both lasers and allows parameter selection by the user. d) The Nd: YAG laser head. e) The frequency doubling crystal. g) The optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that specifically proves the Fotona QX Nd:YAG/KTP Laser System meets acceptance criteria. The document is a 510(k) premarket notification for the device, which aims to demonstrate substantial equivalence to previously cleared predicate devices, rather than presenting a de novo study with specific performance metrics and acceptance criteria.

    Therefore, I cannot extract the requested information. The document focuses on:

    • General Information: Company, contact, device trade names, classification.
    • Device Description: Technical specifications of the laser system (Nd:YAG and KTP Nd:YAG wavelengths, energy delivery, spot sizes).
    • Intended Use: Clinical applications for both 1064 nm and 532 nm wavelengths (e.g., tattoo removal, pigmented lesions, hair removal, skin resurfacing, soft tissue ablation).
    • Summary of Substantial Equivalence: Comparison of the Fotona QX system's design features and intended uses to three predicate devices (Spectra-VRM, Medlite C6, and Palomar Q-YAG) to argue that it raises no new questions of safety or effectiveness.
    • FDA Correspondence: Letter from the FDA granting substantial equivalence.
    • Indications for Use Statement: Formal list of approved clinical applications.

    The document lacks information on:

    1. Acceptance Criteria Table: There is no table defining specific performance metrics and their acceptance thresholds.
    2. Reported Device Performance: No clinical study results or performance data (e.g., efficacy rates, side effect profiles, a specific measure of "success" for tattoo removal or lesion treatment) are presented.
    3. Sample Size and Data Provenance: No mention of test set sample sizes, country of origin, or whether any data was retrospective or prospective.
    4. Number and Qualifications of Experts: No experts are mentioned as establishing ground truth for any test set.
    5. Adjudication Method: Not applicable as no ground truth establishment is described.
    6. MRMC Comparative Effectiveness Study: No such study is described, nor any effect size of AI assistance.
    7. Standalone Performance: Not applicable as this is not an AI/algorithm-only device.
    8. Type of Ground Truth: No ground truth (expert consensus, pathology, outcomes data) is mentioned as being used for any study.
    9. Training Set Sample Size: Not applicable as this is not an AI/machine learning model where a training set would be used.
    10. How Training Set Ground Truth Was Established: Not applicable.

    This 510(k) submission is primarily a regulatory document demonstrating similarity to existing devices, not a scientific publication detailing a new clinical study.

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