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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 K222492
Device Name Hope&Her Vaginal Dilators
Applicant
Lujena, Inc.
772 Jamacha Rd., #800
El Cajon,  CA  92019
Applicant Contact Troy Gemmer
Correspondent
Matrix Medical Consulting, Inc.
8880 Rio San Diego Dr. Suite 800
San Diego,  CA  92108
Correspondent Contact Alan Donald
Regulation Number884.3900
Classification Product Code
HDX  
Date Received08/17/2022
Decision Date 06/27/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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