FDA.reportPublic FDA data

LUJENA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30295828583029582858LUJENA, INC.1N2026-01-0111447 Rolling Hills Dr. El Cajon CA US 92020

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860012225002Hope&Her Vaginal Dilators - Hope&Her Vaginal Dilators are indicated to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex. The set includes 6 comfortable dilator sizes and an easy-to-attach universal handle. The dilators have a silky-smooth, seamless texture and are not made with BPA, Latex, or silicone. The patented, gentle-tapered design promotes an easy size transition from the smallest size up through the largest. The handle locks on easily and is very study to allow PT muscle manipulation.6194491200care@vaginismus.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3211821384157459K233689Hope&Her Vaginal DilatorsHDX2024-05-02
3211821606916808K222492Hope&Her Vaginal DilatorsHDX2023-06-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HDX22024-05-02

PMN#

GUDID#

Hope&Her Vaginal Dilators - Hope&Her Vaginal Dilators are indicated to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex. The set includes 6 comfortable dilator sizes and an easy-to-attach universal handle. The dilators have a silky-smooth, seamless texture and are not made with BPA, Latex, or silicone. The patented, gentle-tapered design promotes an easy size transition from the smallest size up through the largest. The handle locks on easily and is very study to allow PT muscle manipulation.

LUJENA, INC.

2024-11-15