BEUDAMED
    Product Code: HKM FDA class 1 21 CFR 886.1780

    Retinoscope, Battery-Powered

    Ophthalmic

    The Battery-Powered Retinoscope is a portable, battery-operated ophthalmic instrument used to perform retinoscopy, an objective technique for determining a patient's refractive error by observing the reflex of a light beam from the retina. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is HKM, regulated under 21 CFR 886.1780, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.

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    510(k)s
    7
    FEI Numbers
    23
    Registration Numbers
    23
    Unique Applicants
    3
    Years Active
    12

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    Basic Information

    Product Code
    HKM
    Device Class
    FDA class 1
    Regulation Number
    886.1780
    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 7 510(k) clearances via K numbers.

    K Number Device Name
    K964338 RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT
    K950795 STREAK RETINOSCOPE RX-RP
    K950794 STREAK RETINOSCOPE RX-RC
    K950793 SPOT RETINOSCOPE RX-3SP
    K950792 STREAK RETINOSCOPE RX-3A
    K950791 STREAK RETINOSCOPE RX-3
    K840840 GENERATED RETINAL REFLEX IMAGERY SYS

    FEI Numbers

    This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.