BEUDAMED
    Product Code: PYU FDA class 1 21 CFR 878.4820

    Sponge, Eyelid Cleaning, Powered

    General, Plastic Surgery

    The Sponge, Eyelid Cleaning, Powered is a powered device intended for use by healthcare professionals to cleanse the eyelid margins and eyelashes, typically used in the management of blepharitis or prior to ophthalmic procedures. It is classified as a Class 1 device under regulation 878.4820, subject to general controls and exempt from 510(k) requirements under the De Novo pathway classification. The product code is PYU, reviewed by the Ophthalmic (OP) panel. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    0
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    0
    Years Active
    —

    Research product code PYU in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    PYU
    Device Class
    FDA class 1
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    OP
    Submission Type
    4

    Device Characteristics

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

    Definition

    This device type is intended to cleanse the eyelid margins and eyelashes by a healthcare professional.

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.