BEUDAMED
    Product Code: HJN FDA class 1 21 CFR 886.1945

    Transilluminator, Battery-Powered

    Ophthalmic

    The Battery-Powered Ophthalmic Transilluminator is a portable, battery-operated light source used to illuminate ocular and periocular structures, helping clinicians detect abnormalities such as masses or fluid within the eye or orbit. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without any premarket notification requirement. The product code is HJN, regulated under 21 CFR 886.1945, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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    510(k)s
    3
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    3
    Years Active
    4

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    Basic Information

    Product Code
    HJN
    Device Class
    FDA class 1
    Regulation Number
    886.1945
    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

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    Related 510(k) Clearances

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

    K Number Device Name
    K941035 VENOSCOPE
    K912747 LULMITEX NEONATAL TRANSILLUMINATOR
    K901309 SYLVAN PEDIASCAN 200 TRANSILLUMINATOR

    FEI Numbers

    This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.