BEUDAMED
    Product Code: HOF FDA class 1 21 CFR 886.4350

    Burr, Corneal, Manual

    Ophthalmic

    A Manual Corneal Burr is a hand-operated ophthalmic instrument used to abrade and remove superficial corneal lesions, rust rings from metallic foreign bodies, or epithelial irregularities by gentle mechanical scraping of the corneal surface. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket notification or approval. It carries product code HOF and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HOF
    Device Class
    FDA class 1
    Regulation Number
    886.4350
    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
    K884924 VISI-WIPE

    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.