K241443

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)

510(k) number: K241443
Device name: 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. CA
Product code: NUC — Lubricant, Personal
Decision date: 2025-01-21
Date received: 2024-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Obstetrics/Gynecology

PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K241443.pdf

Official FDA record: K241443

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.