510(k) K212260
K212260 is an FDA 510(k) premarket notification submitted by Valencia Naturals, Inc. for the device "Sensuva Premium Silicone Personal Lubricant". The FDA issued a decision of Substantially Equivalent on Apr 13, 2022. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Valencia Naturals, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 13, 2022
- Date Received
- Jul 20, 2021
- 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.