510(k) K261292
K261292 is an FDA 510(k) premarket notification submitted by PR Personal Care Laboratories for the device "PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)". The FDA issued a decision of Substantially Equivalent on June 11, 2026. 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
- June 11, 2026
- Date Received
- April 20, 2026
- 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
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.