# K242958: Joylux Intimacy Gel (PG3100)

- Pathway: 510(k) (Traditional)
- Applicant: Joylux, Inc.
- Decided: Mar 20, 2025 after 176 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: 6 generations back to K810310 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221328: Bloomi Smooth Water Based Lubricant, The Bloomi Inc.. (2022) Summary page 5.

## Indications for use
The Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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. This product is not compatible with polyurethane condoms

Source page: https://510kreport.com/device/K242958
Methodology: https://510kreport.com/methodology