# K101098: Replens Long-Lasting Vaginal Moisturizer (35G Tube with Reusable Applicator) Model: 83035

- Pathway: 510(k) (Traditional)
- Applicant: Lil Drug Store Products, Inc.
- Decided: Aug 17, 2010 after 119 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). 3 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062682: CVS Personal Lubricant and Moisturizer, Lake Consumer Products, Inc. (2007) 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
- K201612: Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 (2021), 1 descendant of its own
- K190752: Satisfaite (2019), 1 descendant of its own

## Indications for use
Replens 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 natural rubber latex condoms and synthetic (polyurethane and polyisoprene) condoms.

Source page: https://510kreport.com/device/K101098
Methodology: https://510kreport.com/methodology