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)

FDA 510(k) K241443 · Hathor Professional Skincare , Ltd.

Substantially Equivalent

510(k) numberK241443

Submission

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.
Victoria, CA
Received
May 22, 2024
Decision date
January 21, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NUC – Lubricant, Personal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5300
Specialty
Obstetrics/Gynecology

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.

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K253989HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based…NUC · Traditional Maxigen Biotech, Inc.09/03/2026SE
K261905BUM OilNUC · Traditional Bumlicious, LLC (DBA “Bumlicious”)08/07/2026SE
K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional Pinkslip, LLC07/09/2026SE
K261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesNUC · Traditional PCCA, Inc.07/06/2026SE
K254011Flow Water-Based Personal LubricantNUC · Traditional LBDO Group, Inc.06/22/2026SE
K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)NUC · Traditional PR Personal Care Laboratories06/11/2026SE
K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional Hathor Professional Skincare , Ltd.06/09/2026SE
K260068pjur NATURE Touch, 100 mlNUC · Traditional Pjur Group Luxembourg S.A.05/21/2026SE
K254101Julva Velvé Water-Based Personal LubricantNUC · Traditional Golden Isles Medical, Inc.04/16/2026SE
K260007Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…NUC · Traditional Hudi Pharma Srl04/01/2026SE

More from Hudi Pharma Srl

510(k)DeviceDecision
K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional 06/09/2026SE
K250629Sutil Rich Personal LubricantNUC · Traditional 05/02/2025SE

Questions and answers

When was 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) cleared by the FDA?

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) (K241443) received a 510(k) decision of Substantially Equivalent on January 21, 2025, 244 days after the submission was received.

What is the product code of K241443?

The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.