FDA.reportPublic FDA data

510(k) K233689

Device
Hope&Her Vaginal Dilators
Applicant
Lujena, Inc.
510(k) number
K233689
Product code
HDX
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-02
Date received
2023-11-17
Regulation
884.3900
Classification name
Dilator, Vaginal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
Troy Gemmer
Address
11447 Rolling Hills Dr. El Cajon CA US 92020 92020

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HDX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241748Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose2024-08-14
K222492Hope&Her Vaginal DilatorsLujena, Inc.2023-06-27
K231430Intimate Rose Vaginal DilatorsPlus EV Holdings Dba Intimate Rose2023-06-07
K220035Milli Vaginal DilatorMaterna Medical2023-02-27
K211959Milli Vaginal DilatorMaterna Medical2021-12-01
K130273PANPAC VAGINAL DILATORSPanpac Medical Corporation2013-08-08
K071754NEO-VAGINA SURGERY SET AND ACCESSORIESKARL STORZ Endoscopy-America, Inc.2009-01-07
K003380BIOTEQUE VAGINAL DILATORBioteque America, Inc.2001-01-29