510(k) K191480
K191480 is an FDA 510(k) premarket notification submitted by Trigg Laboratories, Inc. D/B/A Wet International for the device "Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid)". The FDA issued a decision of Substantially Equivalent on Oct 11, 2019. 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
- Oct 11, 2019
- Date Received
- Jun 4, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lubricant, Personal
- Device Class
- Class II
- Regulation Number
- 884.5300
- Review Panel
- OB
- Submission Type
- 510(k)
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.