BEUDAMED
    Product Code: HOI FDA class 1 21 CFR 886.5840

    Spectacle, Magnifying

    Ophthalmic

    Magnifying Spectacles are optically powered eyeglasses designed to enlarge the apparent size of objects for individuals with low vision or for use in tasks requiring close-up visual precision, providing passive optical magnification without electronic components. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket submission. It carries product code HOI and is regulated under 21 CFR 886.5840, within the Ophthalmic medical specialty.

    View on FDA
    510(k)s
    11
    FEI Numbers
    733
    Registration Numbers
    734
    Unique Applicants
    11
    Years Active
    14

    Basic Information

    Product Code
    HOI
    Device Class
    FDA class 1
    Regulation Number
    886.5840
    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 11 510(k) clearances via K numbers.

    K Number Device Name
    K943613 NIL
    K930435 SPECTACLE FRAMES
    K931328 PYRAMID SUNGLASSES/PYRAMID READING GLASSES
    K910329 SUNGLASSES
    K854854 SYSTEMS OF SIGHT LOW VISION EYEWARE
    K844716 MAGNIFYING SPECTACLES W/PLASTIC LENSES
    K844038 VISITEC MAGNIFYING SPECTACLES
    K842835 BRILLETTE MODEL
    K820732 LA VEL LATERAL VIEW EXTENSION LENS
    K813548 UVEX MINI-SPECS
    K801733 FENZL RETICLE

    FEI Numbers

    This FDA classification entry is associated with 733 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 734 registration numbers. Click on an entry to view related FDA registrations.