# K070587: Elegance Woman's Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Julie Williams, Pa-C
- Decided: Apr 10, 2008 after 406 days
- Product code: NUC (Lubricant, Personal)
- Device class: 2
- Regulation: 21 CFR 884.5300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K810310 (1981). 5 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955648: K-Y Personal Lubricant, Ortho Pharmaceutical Corp. (1996) Summary page 1.
- K033076: Lifestyles Liquid Personal Lubricant, Ansell Healthcare, Inc. (2003) Summary page 1.
- K032124: Durex Play Lubricant, Ssl Americas, Inc. (2004) Summary page 1.

## Most influential descendants
- K150883: HyaloGYN Vaginal Hydrating Gel (2015), 9 descendants of its own
- K211998: Desnuda Reflect (2021), 6 descendants of its own
- K241443: Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) (2025), 1 descendant of its own
- K261177: PINKSLIP Water-Based Personal Lubricant and Moisturizer (2026), 0 descendants of its own
- K261292: PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) (2026), 0 descendants of its own

## Indications for use
Elegance Woman's Lubricant is a non-sterile, oil-based personal lubricant formulated to supplement the body’s own natural lubricating fluids to provide personal lubrication when vaginal dryness causes discomfort. Warning: Do not use this lubricant with condoms. It may weaken the condom's physical properties and make it more likely to break.

Source page: https://510kreport.com/device/K070587
Methodology: https://510kreport.com/methodology