# K201612: Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5

- Pathway: 510(k) (Traditional)
- Applicant: Viramal Limited
- Decided: Sep 2, 2021 after 444 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: 4 generations back to K810310 (1981). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101098: Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035, Lil Drug Store Products, Inc. (2010) Summary page 4.

## Most influential descendants
- K231794: Elegant™ Advanced CompHort (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K201612
Methodology: https://510kreport.com/methodology