BEUDAMED
    Product Code: HNL FDA class 1 21 CFR 886.4350

    Probe, Lachrymal

    Ophthalmic

    A Lachrymal Probe is a thin, elongated ophthalmic instrument used to dilate and explore the lacrimal drainage system, including the puncta, canaliculi, and nasolacrimal duct, to diagnose or treat obstruction of the tear drainage pathway. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket submission. It carries product code HNL and is regulated under 21 CFR 886.4350, within the Ophthalmic medical specialty.

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    510(k)s
    10
    FEI Numbers
    155
    Registration Numbers
    155
    Unique Applicants
    8
    Years Active
    8

    Basic Information

    Product Code
    HNL
    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 10 510(k) clearances via K numbers.

    K Number Device Name
    K843491 CONCEPT FIBER OPTIC CANALICULUS INTUBA
    K840861 TSE-ANDERSON MODIFIED LACRIMAL GROOV
    K833671 STERILE OIL AND GUIDEWIRE
    K831901 LACIMAL INTUBATION SETS
    K813187 PILLING LACRIMAL INTUBATION SYSTEM
    K812255 ETHICON LACRIMAL STENT
    K802845 CONCEPT CANALICULUS INTUBATION SET
    K801232 JACKSON LACRIMAL INTUBATION SET
    K800089 CRAWFORD LACRIMAL INTUBATION SET
    K770194 NASO-LACRIMAL DUCT INSERT

    FEI Numbers

    This FDA classification entry is associated with 155 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 155 registration numbers. Click on an entry to view related FDA registrations.