BEUDAMED
    Product Code: HNS FDA class 1 21 CFR 886.4350

    Expressor

    Ophthalmic

    An Expressor is a manual ophthalmic surgical instrument used to apply controlled pressure to the eye to facilitate expression of the lens nucleus during extracapsular cataract extraction or other intraocular surgical procedures. This device is FDA Class 1 (lowest risk), requiring only general controls without premarket notification. It carries product code HNS and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

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    510(k)s
    0
    FEI Numbers
    20
    Registration Numbers
    20
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HNS
    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 20 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.