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)
by Hathor Professional Skincare, Ltd.
510(k) K241443
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK241443 | Date21 Jan 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NUC
- Models / Variants
- FDA applicant
- Hathor Professional Skincare , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5300
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Sutil Luxe Personal Lubricant is classified as a personal lubricant, designed to moisturize and provide lubrication for penile and vaginal application. These products are intended to enhance comfort and ease during intimate sexual activity by supplementing natural bodily lubrication.
Supplied as single-use applicators, these lubricants are intended for non-medical use in personal intimate care. They are classified under FDA regulation 884.5300 as Class II devices, with a 510(k) clearance (K241443) under the Traditional 510(k) review pathway, determined to be Substantially Equivalent. Each variant is available in distinct flavours and model numbers, adhering to obstetrics/gynecology medical specialty classifications.