BEUDAMED
    Product Code: LQE FDA class 3

    Implant, Corneal, Refractive

    Unknown

    The Corneal Refractive Implant is a surgically placed device inserted into or on the cornea to alter its refractive power and correct refractive errors such as myopia, hyperopia, or astigmatism. It is classified as a Class 3 (highest risk) device under FDA regulations, requiring Premarket Approval (PMA), given the serious risks of irreversible corneal damage and vision impairment associated with permanent intraocular or intracorneal placement. The product code is LQE; no regulation number or specific medical specialty code is listed. This device carries the implant flag, as it is designed for permanent or semi-permanent surgical placement.

    View on FDA
    510(k)s
    0
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LQE
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OP
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.