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510(k) Data Aggregation
K Number
K233689Device Name
Hope&Her Vaginal Dilators
Manufacturer
Lujena, Inc.
Date Cleared
2024-05-02
(167 days)
Product Code
HDX
Regulation Number
884.3900Why 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
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K Number
K222492Device Name
Hope&Her Vaginal Dilators
Manufacturer
Lujena, Inc.
Date Cleared
2023-06-27
(314 days)
Product Code
HDX
Regulation Number
884.3900Why 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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