510(k) K190150
K190150 is an FDA 510(k) premarket notification submitted by Fairhaven Health, LLC for the device "Sage 2-in-1 Personal Lubricant and Moisturizer". The FDA issued a decision of Substantially Equivalent on July 16, 2019. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Fairhaven Health, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 2019
- Date Received
- January 30, 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
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.