510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233689Substantially Equivalent

Hope&Her Vaginal Dilators

Lujena, Inc., El Cajon CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K233689 is the FDA 510(k) clearance record for Hope&Her Vaginal Dilators, a class II device, cleared for Lujena, Inc. on under FDA product code HDX (Dilator, Vaginal). FDA records list 2 510(k) clearances for Lujena, Inc., from to . As of , FDA records show no recalls naming K233689.

Clearance record

Decision date
Received
(167 days to decision)
Product code
HDX Dilator, Vaginal
Regulation
21 CFR 884.3900
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Lujena, Inc. 11447 Rolling Hills Dr., El Cajon CA
510(k) summary
Statement
Third party review
No

Clearances, product code HDX

Trailing 12 months

FDA records hold no clearances under product code HDX in the trailing twelve months.

FDA records show no clearances under product code HDX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HDX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260