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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vaginal
510(k) Number K233689
Device Name Hope&Her Vaginal Dilators
Applicant
Lujena, Inc.
11447 Rolling Hills Dr.
El Cajon,  CA  92020
Applicant Contact Troy Gemmer
Correspondent
Lujena, Inc.
11447 Rolling Hills Dr.
El Cajon,  CA  92020
Correspondent Contact Troy Gemmer
Regulation Number884.3900
Classification Product Code
HDX  
Date Received11/17/2023
Decision Date 05/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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