BEUDAMED
    Product Code: HOR FDA class 1 21 CFR 886.1840

    Simulatan (Including Crossed Cylinder)

    Ophthalmic

    A Simulatan (Including Crossed Cylinder) is an ophthalmic diagnostic instrument used in refraction examinations to simultaneously present different visual targets or optical conditions to the two eyes, facilitating the assessment of binocular vision, fusion, and refractive error including astigmatism. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification. It carries product code HOR and is regulated under 21 CFR 886.1840, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.

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    510(k)s
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HOR
    Device Class
    FDA class 1
    Regulation Number
    886.1840
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K873915 JACKSON CROSS CYLINDER TEST

    FEI Numbers

    This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.