BEUDAMED
    Product Code: HMZ FDA class 1 21 CFR 886.4350

    Trabeculotome

    Ophthalmic

    The Trabeculotome is a surgical ophthalmic instrument used in trabeculotomy procedures to incise or open the trabecular meshwork of the eye, facilitating aqueous humor drainage and reducing intraocular pressure in the treatment of glaucoma, particularly congenital and juvenile forms. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without a premarket notification requirement. The product code is HMZ, regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty. No special risk flags apply to this device.

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    510(k)s
    0
    FEI Numbers
    34
    Registration Numbers
    34
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HMZ
    Device Class
    FDA class 1
    Regulation Number
    886.4350
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.