510(k) K203654
K203654 is an FDA 510(k) premarket notification submitted by Solevy Co., LLC for the device "Solevy Co. LLC Water-Based Personal Lubricant". The FDA issued a decision of Substantially Equivalent on Apr 19, 2021. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Solevy Co., LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 19, 2021
- Date Received
- Dec 15, 2020
- 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.