Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)— 510(k) K252914
Substantially EquivalentHathor Professional Skincare , Ltd.
FDA 510(k) clearance K252914 for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147), Substantially Equivalent on 2026-06-09. Applicant: Hathor Professional Skincare , Ltd.. Device class: 2.
Summary
Hathor Professional Skincare's Sutil Pure Personal Lubricant is listed in four models, 1148, 1145, 1146, and 1147. It's filed under NUC, personal lubricants, and the record doesn't say how the models differ.
Class II, 21 CFR 884.5300. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Hathor filed from Victoria, Canada. The decision came 270 calendar days after FDA received it (September 12, 2025 to June 9, 2026).
Clearance details
- Applicant
- Hathor Professional Skincare , Ltd.
- Product code
- Product code NUC
- Device class
- Class 2
- Regulation
- 21 CFR 884.5300
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Victoria, CA
Recent devices under product code NUC
view allMore clearances from Hathor Professional Skincare , Ltd.
view allAdverse events under product code NUC
product code NUC- Other
- 8
- Total
- 8
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.