BEUDAMED
    Product Code: HQS FDA class 1 21 CFR 886.4070

    Burr, Corneal, Ac-Powered

    Ophthalmic

    An AC-Powered Corneal Burr is an electrically powered ophthalmic instrument that uses a rotating burr tip to remove corneal rust rings, superficial foreign bodies, or irregular epithelium from the corneal surface with motor-driven precision and consistent rotational speed. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification or approval. It carries product code HQS and is regulated under 21 CFR 886.4070, within the Ophthalmic medical specialty.

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

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    Basic Information

    Product Code
    HQS
    Device Class
    FDA class 1
    Regulation Number
    886.4070
    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
    K971078 HYDROBRUSH (TM) KERATOME

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.