BEUDAMED
    Product Code: HNH FDA class 1 21 CFR 886.4350

    Ring, Ophthalmic (Flieringa)

    Ophthalmic

    An Ophthalmic Ring (Flieringa) is a small metal ring used in eye surgery, placed on the sclera to maintain the shape of the eye and prevent collapse during procedures such as corneal transplantation or intraocular surgery. This device is FDA Class 1 (lowest risk), subject only to general controls without requiring premarket notification. It carries product code HNH and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

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    510(k)s
    7
    FEI Numbers
    92
    Registration Numbers
    92
    Unique Applicants
    3
    Years Active
    8

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    Basic Information

    Product Code
    HNH
    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

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 7 510(k) clearances via K numbers.

    K Number Device Name
    K912269 LANDERS NOTCHED IRRIGATING VITRECTOMY LENS RING
    K912268 LANDERS NOTCHED VITRECTOMY LENS RING
    K912151 LANDERS THREE STRUT VITRECTOMY LENS RING
    K902496 LANDERS VITRECTOMY LENS RING W/INFUSION
    K863775 RK VACUUM FIXATION RING SYSTEM
    K850991 LANDERS VITRECTOMY LENS RING SYSTEMS
    K832912 GELENDER VACUUM FIXATION RING SYS

    FEI Numbers

    This FDA classification entry is associated with 92 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 92 registration numbers. Click on an entry to view related FDA registrations.