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510(k) K222492

Device
Hope&Her Vaginal Dilators
Applicant
Lujena, Inc.
510(k) number
K222492
Product code
HDX
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-27
Date received
2022-08-17
Regulation
884.3900
Classification name
Dilator, Vaginal
Medical specialty
Obstetrics/Gynecology
Review panel
Obstetrics/Gynecology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Troy Gemmer
Address
772 Jamacha Rd., #800 El Cajon CA US 92019 92019

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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
K233689Hope&Her Vaginal DilatorsLujena, Inc.2024-05-02
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