510(k) K242958
K242958 is an FDA 510(k) premarket notification submitted by Joylux, Inc. for the device "Joylux Intimacy Gel (PG3100)". The FDA issued a decision of Substantially Equivalent on Mar 20, 2025. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 20, 2025
- Date Received
- Sep 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Lubricant, Personal
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
This device 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 may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.