510(k) · Cleared
ClearedElegance Woman's Lubricant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Julie Williams, Pa-C · NUC Lubricant, Personal
Cleared on Apr 10, 2008 as substantially equivalent to K955648 (Ortho Pharmaceutical Corp., 1996) and 2 other predicates after a 406-day review. Its family tree reaches back 3 generations to 1981. 11 later devices descend from it.
- Decided
- Apr 10, 2008
- Review
- 406 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K810310 (1981). 5 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 2 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 1 generation backK033076 Lifestyles Liquid Personal LubricantAnsell Healthcare, Inc. · 2003
- This deviceK070587 Elegance Woman's LubricantJulie Williams, Pa-C · 2008
- Descendant · cites it directly · 9 of its ownK150883 HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015
- Descendant · 2 generations on · 6 of its ownK211998 Desnuda ReflectGood Clean Love, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK241443 Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil…Hathor Professional Skincare, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK261177 PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC · 2026
- Descendant · 3 generations on · 0 of its ownK261292 PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal…PR Personal Care Laboratories · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K150883HyaloGYN Vaginal Hydrating GelFidia Farmaceutici S.P.A. · 2015 · cites it directly9descendants
- K211998Desnuda ReflectGood Clean Love, Inc. · 2021 · 2 generations on6descendants
- K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…Hathor Professional Skincare, Ltd. · 2025 · 3 generations on1descendant
- K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPinkslip, LLC · 2026 · 3 generations on0descendants
- K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care Laboratories · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −2 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −1 | K033076 | Lifestyles Liquid Personal Lubricant | Ansell Healthcare, Inc. | 2003 | — |
| 0 (this device) | K070587 | Elegance Woman's Lubricant | Julie Williams, Pa-C | 2008 | — |
| +1 | K150883 | HyaloGYN Vaginal Hydrating Gel | Fidia Farmaceutici S.P.A. | 2015 | — |
| +2 | K211998 | Desnuda Reflect | Good Clean Love, Inc. | 2021 | — |
| +3 | K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe… | Hathor Professional Skincare, Ltd. | 2025 | — |
| +3 | K261177 | PINKSLIP Water-Based Personal Lubricant and Moisturizer | Pinkslip, LLC | 2026 | — |
| +3 | K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) | PR Personal Care Laboratories | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NUC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NUC device
- #1 K211998 Desnuda Reflectscore 18.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K955648 | K-Y Personal LubricantSummary page 1…ication Name: Lubricant, Vaginal, Patient (21 CFR 880.6375, Product Code: MMS) Ill. Predicate Devices Predicate Device 510 (k) control # K-Y™ Liquid Personal ubricant (K955648) LifeStyles® Liquid Personal Lubricant (K033076) Durex Play™ Personal Lubricant (K032124) IV. Description of Device Elegance Wo… | 1996 |
| * | K033076 | Lifestyles Liquid Personal LubricantSummary page 1…R 880.6375, Product Code: MMS) Ill. Predicate Devices Predicate Device 510 (k) control # K-Y™ Liquid Personal ubricant (K955648) LifeStyles® Liquid Personal Lubricant (K033076) Durex Play™ Personal Lubricant (K032124) IV. Description of Device Elegance Woman's Lubricant is a non-sterile oil-based perso… | 2003 |
| * | K032124 | Durex Play LubricantSummary page 1…icate Devices Predicate Device 510 (k) control # K-Y™ Liquid Personal ubricant (K955648) LifeStyles® Liquid Personal Lubricant (K033076) Durex Play™ Personal Lubricant (K032124) IV. Description of Device Elegance Woman's Lubricant is a non-sterile oil-based personal lubricant formulated to supplement th… | 2004 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 4 companies; a new generation was cleared every 9.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K150883 (Fidia Farmaceutici S.P.A., 2015) has gone furthest, with 9 descendants of its own.
- 14 other devices also cite its predicate K955648.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · NUC
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUC
221in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUC
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NUC
13in 2025
MAUDE reports naming product code NUC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 150 | 0 | 0 |
| 2008 | 7 | 271 | 1 | 6 |
| 2009 | 2 | — | 1 | 13 |
| 2010 | 4 | 124 | 0 | 2 |
| 2011 | 2 | — | 0 | 3 |
| 2012 | 6 | 269 | 0 | 6 |
| 2013 | 11 | 205 | 3 | 5 |
| 2014 | 11 | 264 | 0 | 14 |
| 2015 | 21 | 251 | 0 | 8 |
| 2016 | 14 | 181 | 0 | 14 |
| 2017 | 14 | 175 | 0 | 19 |
| 2018 | 15 | 114 | 0 | 6 |
| 2019 | 13 | 150 | 0 | 8 |
| 2020 | 19 | 180 | 0 | 2 |
| 2021 | 20 | 143 | 0 | 7 |
| 2022 | 14 | 112 | 0 | 7 |
| 2023 | 13 | 159 | 0 | 15 |
| 2024 | 6 | 178 | 0 | 13 |
| 2025 | 11 | 221 | 0 | 13 |
| 2026 | 12 | 104 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070587 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070587: Elegance Woman's Lubricant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070587
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026