BEUDAMED
    Product Code: HRB FDA class 1 21 CFR 878.4700

    Microscope, Operating, Non-Electric, Ophthalmic

    General, Plastic Surgery

    A Non-Electric Ophthalmic Operating Microscope is a manually operated, non-powered optical microscope used to provide high-magnification stereoscopic visualization of the eye and its structures during ophthalmic surgical procedures such as cataract surgery, corneal transplantation, and vitreoretinal surgery. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HRB and is regulated under 21 CFR 878.4700, within the General, Plastic Surgery medical specialty.

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    510(k)s
    0
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HRB
    Device Class
    FDA class 1
    Regulation Number
    878.4700
    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 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.