Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011) +3 more— 510(k) K241443

Name: FDA 510(k) clearance K241443
Creator: U.S. Food and Drug Administration
Published: 2025-01-21

Substantially Equivalent

Hathor Professional Skincare , Ltd.

FDA 510(k) clearance K241443 for Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011) +3 more, Substantially Equivalent on 2025-01-21. Applicant: Hathor Professional Skincare , Ltd.. Device class: 2.

Clearance details

Device name as filed: 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)
Applicant: Hathor Professional Skincare , Ltd.
Product code: Code NUC
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 2024-05-22
Decision date: 2025-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Victoria, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NUC

product code NUC

Other: 8
Total: 8

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.