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510(k) Data Aggregation

    K Number
    K192755
    Device Name
    Soli-Lite LG4 Galileo
    Manufacturer
    Silhouet-Tone Corporation
    Date Cleared
    2019-12-20

    (81 days)

    Product Code
    GEX,ILY
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K113668,K083183
    Why did this record match?
    Device Name :

    Soli-Lite LG4 Galileo

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

    Blue (410-415mm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

    Red (620-633nm) and Infrared (820-830nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

    Combination of Infrared (820-830mm) and Yellow (585-595mm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

    Device Description

    The Photo-Therapy Device Soli-Lite LG4 Galileo is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs).

    The device produces light in the following regions of the light spectrum:

    • Red (620-633nm)
    • Blue (410-415nm)
    • Sequence of Yellow (585-595nm) and Infra-red (820-830nm) ●

    This device is mainly made up of the base (main frame), the head (irradiator), and the lifting stand. The base unit contains power supply and control system. The user interface software allows the operator to access and control all device functions.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of medical image analysis or AI performance. The document is a 510(k) summary for a phototherapy device (Soli-Lite LG4 Galileo) seeking substantial equivalence to predicate devices. It focuses on device specifications, indications for use, and compliance with general medical device standards.

    Therefore, I cannot extract the requested information regarding:

    1. Table of acceptance criteria and reported device performance: Not present.
    2. Sample size for the test set and data provenance: No such test set is described.
    3. Number of experts used to establish ground truth and qualifications: Not applicable, as there's no ground truth established for AI performance.
    4. Adjudication method: Not applicable.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not present.
    6. Standalone (algorithm only) performance: Not applicable as it's a phototherapy device, not an AI algorithm.
    7. Type of ground truth used: Not applicable.
    8. Sample size for the training set: Not applicable.
    9. How ground truth for the training set was established: Not applicable.

    The "Performance Data" section (Section 8) refers to electrical and photobiological safety standards (e.g., IEC60601-1, IEC60601-1-2, IEC60601-2-57, IEC62471) and software verification, not a clinical or AI performance study with acceptance criteria as typically understood in the context of your questions.

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