BEUDAMED
    Product Code: REG FDA class 2 21 CFR 878.4635

    Suntan Lamp

    General, Plastic Surgery

    The Suntan Lamp (product code REG) is a lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and is intended for use in sunlamp products or fixtures to induce skin tanning. 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
    REG
    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 lamp that produces ultraviolet radiation in the wavelength range of 200 to 400 nanometers in air and that is intended for use in any sunlamp product or fixture.