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510(k) Data Aggregation

    K Number
    K233689
    Device Name
    Hope&Her Vaginal Dilators
    Manufacturer
    Lujena, Inc.
    Date Cleared
    2024-05-02

    (167 days)

    Product Code
    HDX
    Regulation Number
    884.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lujena, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hope&Her Vaginal Dilators are tools intended for controlled dilation of the vagina. They can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
    Device Description
    Not Found
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    K Number
    K222492
    Device Name
    Hope&Her Vaginal Dilators
    Manufacturer
    Lujena, Inc.
    Date Cleared
    2023-06-27

    (314 days)

    Product Code
    HDX
    Regulation Number
    884.3900
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lujena, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hope&Her Vaginal Dilators are indicated for women who need vaginal dilation for an examination, in preparation for a surgical procedure, or for the relief of vaginismus.
    Device Description
    Hope&Her Vaginal Dilators is a series of reusable, non-sterile, single user vaginal dilators that are used by patients to provide passive distention of the vaginal tissues using various sized dilators. The subject device has various sized rigid dilators that range from 15 mm to 38 mm in diameter (15, 22, 26, 30, 34, and 38 mm) and a handle to hold the dilator. The subject device is prescription-only. The subject device is composed polyester and polyamide. The subject device is distributed in heat-seal plastic bags.
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