Elegance Woman's Lubricant
by Julie Williams, Pa-C 510(k)
Active
510(k) K070587
Overview
Elegance Woman's Lubricant is a personal lubricant device intended to supplement the body's own natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort. It is an oil-based formulation designed for use in obstetrics and gynecology applications.
The device is supplied as a non-sterile product and is classified as a Class II medical device under FDA 510(k) clearance K070587. It is regulated under product code NUC and regulation number 884.5300 for obstetrical and gynecological therapeutic devices.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070587 | Date10 Apr 2008 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NUC
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5300
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is Elegance Woman's Lubricant used for?
Elegance Woman's Lubricant is intended to supplement the body's own natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort, specifically in obstetrics and gynecology applications.
Is Elegance Woman's Lubricant sterile or non-sterile, and is it reusable?
The device is supplied as a non-sterile product and is designed for single-use only; it is not intended to be cleaned, sterilized, or reused due to the risk of contamination and degradation of the oil-based formulation.
How is Elegance Woman's Lubricant supplied and what are its key specifications?
Elegance Woman's Lubricant is supplied as an oil-based personal lubricant in a non-sterile condition; specific sizes, volumes, or packaging details are not provided in the device data, but it is classified under product code NUC and regulation number 884.5300 for obstetrical and gynecological therapeutic devices.
What regulatory pathway was used for Elegance Woman's Lubricant and what is its classification?
Elegance Woman's Lubricant received FDA 510(k) clearance under K070587 and is classified as a Class II medical device, determined to be substantially equivalent to a predicate device, with traditional clearance type and OB advisory committee review.