# K220646: Play&Joy InvisiLube Lubricant Capsule

- Pathway: 510(k) (Traditional)
- Applicant: Innovemed Bio-Tech Co., Ltd.
- Decided: Jul 10, 2023 after 493 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: 2 generations back to K062796 (2006). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122061: K-Y Brand Liquibeads, Johnson & Johnson Healthcare Products (2013) Summary page 4.

## Indications for use
Play & Joy InvisiLube Lubricant Capsule is a personal lubricant for over-the counter use, 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, polyisoprene, and polyurethane condoms

Source page: https://510kreport.com/device/K220646
Methodology: https://510kreport.com/methodology