BEUDAMED
    Product Code: LZP FDA class 3 21 CFR 886.4275

    Aid, Surgical, Viscoelastic

    Ophthalmic

    The Viscoelastic Surgical Aid (product code LZP) is an ophthalmic device consisting of a viscoelastic gel injected into the anterior or posterior chamber of the eye during cataract or other intraocular surgery to maintain space, protect the corneal endothelium, and facilitate surgical manipulation. Regulated under 21 CFR 886.4275 and classified as a Class 3 device, it requires Premarket Approval (PMA) due to the risks associated with direct intraocular injection. The device falls under the Ophthalmic specialty. It is not flagged as an implant or life-sustaining device.

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    510(k)s
    0
    FEI Numbers
    24
    Registration Numbers
    24
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    LZP
    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

    FEI Numbers

    This FDA classification entry is associated with 24 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 24 registration numbers. Click on an entry to view related FDA registrations.