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510(k) Data Aggregation

    K Number
    K221523
    Device Name
    Tanning Lamp
    Manufacturer
    Unilam Co., Ltd.
    Date Cleared
    2023-02-15

    (265 days)

    Product Code
    LEJ
    Regulation Number
    878.4635
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K151674
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.

    Device Description

    The Unilam Tanning lamps are high-pressure metal-halide lamps, each comprised of a quartz glass bulb filled with metal halide, mercury, and argon gas, and equipped with 2 electrodes and an electrical connector, to provide ultraviolet light in order to tan the human body.

    AI/ML Overview

    The provided document is a 510(k) summary for a "Tanning Lamp" and focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving algorithms, AI, or human readers. Therefore, most of the requested information regarding acceptance criteria, study design for AI models, human expert involvement, and ground truth establishment for such studies is not available in the document.

    However, I can extract the information related to the device's performance criteria mentioned in the document as part of its substantial equivalence claim.

    Here's the relevant information based on the document:

    1. Table of acceptance criteria and the reported device performance

    Acceptance Criteria (Regulatory Standard)Reported Device Performance
    Requirements of 21 CFR 878.4635 (Sunlamp Products and Ultraviolet Lamps)The subject device emits UV-B and UV-A radiation and fulfills the requirements of 21 CFR 878.4635.
    Performance standard 21 CFR 1040.20 (Sunlamp Products)The subject device fulfills the requirements of 21 CFR 1040.20.
    Ratio of UV-C (200-260nm) to UV-B (260-320nm)
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