BEUDAMED
    Product Code: LWL FDA class 3 21 CFR 886.4275

    Fluid, Intraocular

    Ophthalmic

    The Intraocular Fluid (product code LWL) is an ophthalmic solution injected into the eye during surgical procedures, such as vitreoretinal surgery, to replace or supplement natural ocular fluids and maintain intraocular pressure or clarity. Regulated under 21 CFR 886.4275 and classified as a Class 3 device, it requires Premarket Approval (PMA) given the high risk associated with direct intraocular use. It falls under the Ophthalmic medical specialty and is not flagged as an implant or life-sustaining device.

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    510(k)s
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    LWL
    Device Class
    FDA class 3
    Regulation Number
    886.4275
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    2

    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
    K844895 OMS SILICONE OIL INJECTOR

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.