Sutil Rich Personal Lubricant

FDA 510(k) K250629 · Hathor Professional Skincare , Ltd.

Substantially Equivalent

510(k) numberK250629

Submission

Device name
Sutil Rich Personal Lubricant
Applicant
Hathor Professional Skincare , Ltd.
Victoria, CA
Received
March 3, 2025
Decision date
May 2, 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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More from Hudi Pharma Srl

510(k)DeviceDecision
K252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional 06/09/2026SE
K241443Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla…NUC · Traditional 01/21/2025SE

Questions and answers

When was Sutil Rich Personal Lubricant cleared by the FDA?

Sutil Rich Personal Lubricant (K250629) received a 510(k) decision of Substantially Equivalent on May 2, 2025, 60 days after the submission was received.

What is the product code of K250629?

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