510(k) K241443
K241443 is an FDA 510(k) premarket notification submitted by Hathor Professional Skincare , Ltd. for the device "Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)". The FDA issued a decision of Substantially Equivalent on January 21, 2025. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Hathor Professional Skincare , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2025
- Date Received
- May 22, 2024
- 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.