510(k) K201612
K201612 is an FDA 510(k) premarket notification submitted by Viramal Limited for the device "Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5". The FDA issued a decision of Substantially Equivalent on September 2, 2021. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Viramal Limited has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 2, 2021
- Date Received
- June 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
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.