# K150841: Luvena Enhanced Personal Moisturizer, Luvena Enhanced Personal Lubricant

- Pathway: 510(k) (Traditional)
- Applicant: Laclede, Inc.
- Decided: Dec 29, 2015 after 274 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: 5 generations back to K810310 (1981). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110325: Aqua Lube, Mayer Laboratories, Inc. (2011) Summary page 4.

## Most influential descendants
- K162235: Luvena Vaginal Moisturizer & Lubricant (2017), 0 descendants of its own

## Indications for use
Luvena Enhanced Personal Moisturizer and Luvena Enhanced Personal Lubricant is a personal lubricant, for penile and/or 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 and polyisoprene condoms, but is not compatible with polyurethane condoms.

Source page: https://510kreport.com/device/K150841
Methodology: https://510kreport.com/methodology