BEUDAMED
    Product Code: FXQ FDA class 1 21 CFR 878.4160

    Lens, Camera, Surgical

    General, Plastic Surgery

    A surgical camera lens is an optical component used with surgical camera systems to focus and transmit light, forming clear images of the operative field for recording or live display. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FXQ, regulated under 21 CFR 878.4160, within the General, Plastic Surgery medical specialty. No special flags apply to this device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    FXQ
    Device Class
    FDA class 1
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K821705 NAGASHIMA F60MM ATTACH. LENS

    FEI Numbers

    This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.