510(k) · Cleared
ClearedElegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viramal Limited · NUC Lubricant, Personal
Cleared on Sep 2, 2021 as substantially equivalent to K101098 (Lil Drug Store Products, Inc., 2010) after a 444-day review. Its family tree reaches back 4 generations to 1981. 1 later device descends from it.
- Decided
- Sep 2, 2021
- Review
- 444 days
- Class
- Class II
- Product code
- NUC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K810310 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK810310 K-Y Lubricating JellyJohnson & Johnson Professionals, Inc. · 1981
- 3 generations backK935299 AstroglideBiofilm, Inc. · 1994
- 2 generations backK062682 CVS Personal Lubricant and MoisturizerLake Consumer Products, Inc. · 2007
- 1 generation backK101098 Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable…Lil Drug Store Products, Inc. · 2010
- This deviceK201612 Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5Viramal Limited · 2021
- Descendant · cites it directly · 0 of its ownK231794 Elegant™ Advanced CompHortViramal Limited · 2023
Most influential descendants
Showing 1 of 1 · See all- K231794Elegant™ Advanced CompHortViramal Limited · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K810310 | K-Y Lubricating Jelly | Johnson & Johnson Professionals, Inc. | 1981 | — |
| −3 | K935299 | Astroglide | Biofilm, Inc. | 1994 | — |
| −2 | K062682 | CVS Personal Lubricant and Moisturizer | Lake Consumer Products, Inc. | 2007 | — |
| −1 | K101098 | Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator)… | Lil Drug Store Products, Inc. | 2010 | — |
| 0 (this device) | K201612 | Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 | Viramal Limited | 2021 | — |
| +1 | K231794 | Elegant™ Advanced CompHort | Viramal Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K101098 | Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035Summary page 4…21 CFR. 884.5300 Regulatory Class: II Product Code: NUC (lubricant, personal) Predicate Device: K101098, Replens Long-Lasting Vaginal Moisturizer (Church & Dwight Co., Inc.) The predicate devic… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231794 | Elegant™ Advanced CompHort | 2023 | 0 |
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 40 years and passes through 5 companies; a new generation was cleared every 12.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K231794 (Viramal Limited, 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K101098.
How does its category compare?
All NUC devicesNUC Lubricant, Personal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Elegant™ 2 in 1 Vaginal Moisturizer/ Elegant™ Advanced 5 is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with polyurethane condoms. This product is not compatible with natural rubber latex and polyisoprene condoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201612: Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201612
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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