BEUDAMED
    Product Code: LZS FDA class 3

    Excimer Laser System

    Unknown

    The Excimer Laser System (product code LZS) is an ophthalmic surgical device that uses ultraviolet excimer laser energy (typically at 193nm) to reshape the cornea through photoablation, correcting refractive errors such as myopia, hyperopia, and astigmatism in procedures such as LASIK and PRK. It is classified as a Class 3 device requiring Premarket Approval (PMA) due to the irreversible nature of corneal tissue removal and associated surgical risks. The device has no formal regulation number or medical specialty designation and is reviewed under the Ophthalmic (OP) panel. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    10
    Registration Numbers
    11
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LZS
    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 10 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.