BEUDAMED
    Product Code: FSZ FDA class 2 21 CFR 878.4580

    Light, Surgical, Carrier

    General, Plastic Surgery

    A surgical light carrier is a mechanical support or mounting component used to hold and position surgical lighting units in operating rooms, enabling flexible positioning of the light source. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FSZ, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    0
    FEI Numbers
    22
    Registration Numbers
    22
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    FSZ
    Device Class
    FDA class 2
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 22 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 22 registration numbers. Click on an entry to view related FDA registrations.