BEUDAMED
    Product Code: REF FDA class 2 21 CFR 878.4635

    Suntan Bed

    General, Plastic Surgery

    The Suntan Bed (product code REF) is a bed or other platform designed to incorporate one or more ultraviolet lamps intended for irradiation of any part of the human body with ultraviolet radiation at wavelengths between 200 and 400 nanometers in air, to induce skin tanning. It is a Class 2 device under FDA classification, 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
    REF
    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
    —
    Summary Malfunction Reporting

    Definition

    A bed or other platform that is designed to incorporate one or more ultraviolet lamps and intended for irradiation of any part of the human body, by ultraviolet radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning.