LUJENA, INC.

FDA Device Registration & Listing · El Cajon, CA, US · Registration 3029582858

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3029582858
FEI Number
3029582858
Entity Name
LUJENA, INC.
City/State/Country
El Cajon, CA, US
Establishment Address
11447 Rolling Hills Dr., El Cajon, CA 92020, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Lujena, Inc. (Owner Number: 10088889)
Owner / Operator Contact Address
11447 Rolling Hills Dr., El Cajon, CA 92020, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K222492
PMA Number
N/A

All Registered Proprietary Names

Hope&Her Vaginal Dilators

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HDX Dilator, Vaginal Obstetrics/Gynecology Class 2 884.3900 2023-10-18

Official Correspondent

Troy Gemmer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lujena, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029582858. Last updated year: 2026. Please use registration number 3029582858 when referencing this establishment in official correspondence.
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