BEUDAMED
    Product Code: HRM FDA class 1 21 CFR 878.4700

    Microscope, Operating & Accessories, Ac-Powered, Ophthalmic

    General, Plastic Surgery

    An AC-Powered Ophthalmic Operating Microscope and Accessories is an electrically powered surgical microscope system providing high-magnification binocular visualization with coaxial illumination, used by surgeons performing microsurgical procedures on the eye and adnexa including cataract surgery, corneal grafting, and vitreoretinal operations. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HRM and is regulated under 21 CFR 878.4700, within the General, Plastic Surgery medical specialty.

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    510(k)s
    14
    FEI Numbers
    59
    Registration Numbers
    59
    Unique Applicants
    11
    Years Active
    14

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    Basic Information

    Product Code
    HRM
    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 14 510(k) clearances via K numbers.

    K Number Device Name
    K932720 HM-0970
    K930439 MARCO SURGISCOPE OPERATION MICROSCOPES
    K920641 ALCON OPERATING MICROSCOPES
    K914956 KEELER KONAN SPECULAR MICROSCOPE SP5500
    K891584 S 22 INSTRUMENT STAND
    K891001 MICROSCOPE KNOB COVER, STERILE, DISPOSABLE
    K854440 MODIFIED CLINICAL WIDEFIELD SPECULAR MICROSCOPE 50
    K853855 XTAL X-150 OPERATING MICROSCOPE
    K852586 CROMIC SURGICAL MICROSCOPE MODEL MC-1
    K852150 CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500
    K850270 CORNEAL LIGHT SHIELD
    K844323 KONAN CLINIC MICROSCOPE CLM-100-150
    K822563 OPHTHALMIC MICROSCOPE
    K792083 HAAG-STREIT SLIT LAMP 900

    FEI Numbers

    This FDA classification entry is associated with 59 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 59 registration numbers. Click on an entry to view related FDA registrations.