BEUDAMED
    Product Code: HPY FDA class 1 21 CFR 886.4250

    Unit, Electrolysis, Battery-Powered, Ophthalmic

    Ophthalmic

    A Battery-Powered Ophthalmic Electrolysis Unit is a portable electrically powered device used in ophthalmic practice to perform electrolysis of individual eyelash follicles, treating trichiasis (inward-growing eyelashes) by delivering a controlled electrical current to destroy the hair follicle and prevent regrowth. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification. It carries product code HPY and is regulated under 21 CFR 886.4250, within the Ophthalmic medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    HPY
    Device Class
    FDA class 1
    Regulation Number
    886.4250
    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 1 510(k) clearance via K numbers.

    K Number Device Name
    K903666 OPHTHASONIC A/P III

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.