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510(k) Data Aggregation

    K Number
    K202827
    Device Name
    308nm Excimer UV-light Skin Therapy System
    Manufacturer
    Shenzhen GSD Tech Co., Ltd.
    Date Cleared
    2020-12-15

    (82 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K172273
    Why did this record match?
    Device Name :

    308nm Excimer UV-light Skin Therapy System

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

    The 308nm Excimer UV-light Skin Therapy System is intended to the treatment of psoriasis and vitiligo. It is to be used on intact skin only.

    Device Description

    The 308nm Excimer UV-light Skin Therapy System is ultraviolet light emitting medical device.

    The model GP908B is a desktop device, consisting of a main body, handpiece, footswitch and power cord.

    The model GP908D is a handheld device, consisting of a main body, power cord and adapter.

    308nm Excimer UV-light Skin Therapy System is designed to be used in dermatological practice for the treatment of psoriasis and vitiligo. The lamp is axenon-chloride excimer lamp which utilizes a XeCl gas mixture to generate specific ultraviolet light at wavelength of 308 nm. Users can set the device parameter and determine the machine's state and function on the control touch screen.

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device, the "308nm Excimer UV-light Skin Therapy System," and its substantial equivalence to a predicate device. This document primarily focuses on demonstrating equivalence through technical specifications and adherence to safety standards. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or AI/software algorithm efficacy.

    Specifically, the document discusses:

    • Device Description: A UV light therapy system for psoriasis and vitiligo.
    • Technological Characteristics: Comparison of wavelength, light source, mode of operation, etc., with a predicate device.
    • Nonclinical Tests: Safety (IEC 60601-1), EMC (IEC 60601-1-2), Reliability (IEC 60601-2-57), Biocompatibility (ISO 10993-5, ISO 10993-10), and Software Validation. These are primarily engineering and compliance tests, not clinical performance studies measuring treatment efficacy or algorithm accuracy.

    Therefore, I cannot fulfill your request for the tables and study details as this information is not present in the provided text. The document states that "None of the tests demonstrated any design characteristics that violate the requirements of the Reviewer Guidance or show any safety hazards. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests." This refers to its safety and performance as a device, not its clinical effectiveness in treating patients or the performance of a diagnostics interpreting AI/software.

    The provided document is a 510(k) summary for a physical medical device (an excimer UV-light system), not an AI/software as a medical device (SaMD) or an AI-assisted diagnostic system. The "software validation & verification testing" refers to the embedded control software for the device itself, not an AI intended for diagnostic or prognostic purposes, which would require the kind of clinical validation and ground truth establishment you are asking about.

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