BEUDAMED
    Product Code: REH FDA class 2 21 CFR 878.4635

    Tabletop Sunlamp System

    General, Plastic Surgery

    The Tabletop Sunlamp System (product code REH) is a sunlamp system that sits on a table and is primarily intended to tan the face by irradiating it with ultraviolet radiation at wavelengths between 200 and 400 nanometers in air. It is a Class 2 device requiring 510(k) premarket notification, regulated under 21 CFR 878.4635 under the General and Plastic Surgery medical specialty. It is not implantable, not life-sustaining, and is eligible for third-party 510(k) review.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    REH
    Device Class
    FDA class 2
    Regulation Number
    878.4635
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
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    Summary Malfunction Reporting

    Definition

    A sunlamp system that sits on a table, primarily intended to tan the face by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers.