BEUDAMED
    Product Code: RAB FDA class 2 21 CFR 878.4635

    Sunlamp Products (Pre-Standard)

    General, Plastic Surgery

    The sunlamp products (pre-standard) classification (product code RAB) covers sunlamp products assembled or manufactured before November 9, 1979, predating modern sunlamp performance standards. Classified as Class 2 under General, Plastic Surgery (regulation 878.4635) as of 2014, these devices require 510(k) clearance and are eligible for third-party review. They are GMP-exempt and are not implants or life-sustaining.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    RAB
    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 sunlamp product assembled or manufactured before november 9, 1979. These are Class II medical devices as of 2014.

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.