BEUDAMED
    Product Code: HLG FDA class 1 21 CFR 886.1700

    Pupillometer, Ac-Powered

    Ophthalmic

    The AC-Powered Pupillometer is an electrically powered ophthalmic instrument used to measure the diameter of the pupil, typically for monitoring neurological status, fitting contact lenses, or assessing pupillary response in clinical settings. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without a premarket notification requirement. The product code is HLG, regulated under 21 CFR 886.1700, within the Ophthalmic medical specialty. No special risk flags apply to this device.

    View on FDA
    510(k)s
    3
    FEI Numbers
    29
    Registration Numbers
    30
    Unique Applicants
    3
    Years Active
    12

    Research product code HLG in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    HLG
    Device Class
    FDA class 1
    Regulation Number
    886.1700
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K920937 COMPUTERIZED PUPIL
    K895609 PUPIL PATHWAY ANALYZER (PPA)
    K802351 F110 PHOTO BINOCULAR OPHTHALMOSCOPE

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.