Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)

FDA 510(k) K252914 · Hathor Professional Skincare , Ltd.

Substantially Equivalent

510(k) numberK252914

Submission

Device name
Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)
Applicant
Hathor Professional Skincare , Ltd.
Victoria, CA
Received
September 12, 2025
Decision date
June 9, 2026
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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More from Guangzhou Haoyimai Trading Co., Ltd.

510(k)DeviceDecision
K250629Sutil Rich Personal LubricantNUC · Traditional 05/02/2025SE
K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…NUC · Traditional 01/21/2025SE

Questions and answers

When was Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) cleared by the FDA?

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (K252914) received a 510(k) decision of Substantially Equivalent on June 9, 2026, 270 days after the submission was received.

What is the product code of K252914?

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