Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Water Solubility Human Body Lubricant

K-Number: K243107 · 2025-05-09

ApplicantDongguan Yanxuan Biotechnology Co., Ltd.
Decision Date2025-05-09
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Water Solubility Human Body Lubricant is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Yanxuan Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-09 under 510(k) number K243107. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Water Solubility Human Body Lubricant?

Water Solubility Human Body Lubricant is a medical device that received FDA 510(k) clearance on 2025-05-09. The listed applicant is Dongguan Yanxuan Biotechnology Co., Ltd.. The 510(k) number is K243107.

When did Water Solubility Human Body Lubricant receive FDA 510(k) clearance?

Water Solubility Human Body Lubricant received FDA 510(k) clearance on 2025-05-09, under 510(k) number K243107.

Who is the listed applicant for Water Solubility Human Body Lubricant?

The FDA 510(k) record lists Dongguan Yanxuan Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Water Solubility Human Body Lubricant?

The FDA product code for Water Solubility Human Body Lubricant is NUC.

Related Devices (Code: NUC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261905BUM OilBumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP Water-Based Personal Lubricant and MoisturizerPINKSLIP, LLCK261909Plum Vagiceuticals™ Vaginal Moisturizing SuppositoriesPCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.K261292PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)PR Personal Care LaboratoriesK252914Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)Hathor Professional Skincare , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑