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

FDA 510(k)

Julva Velvé Water-Based Personal Lubricant

K-Number: K254101 · 2026-04-16

ApplicantGolden Isles Medical, Inc.
Decision Date2026-04-16
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Julva Velvé Water-Based Personal Lubricant is a medical device manufactured by Golden Isles Medical, Inc.. It received FDA 510(k) clearance on 2026-04-16 under approval number K254101. 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 Julva Velvé Water-Based Personal Lubricant?

Julva Velvé Water-Based Personal Lubricant is a medical device that received FDA 510(k) clearance on 2026-04-16. It is manufactured by Golden Isles Medical, Inc.. The 510(k) number is K254101.

When was Julva Velvé Water-Based Personal Lubricant approved by the FDA?

Julva Velvé Water-Based Personal Lubricant received FDA 510(k) clearance on 2026-04-16, under approval number K254101.

What company makes Julva Velvé Water-Based Personal Lubricant?

Julva Velvé Water-Based Personal Lubricant is manufactured by Golden Isles Medical, Inc..

What is the FDA product code for Julva Velvé Water-Based Personal Lubricant?

The FDA product code for Julva Velvé Water-Based Personal Lubricant is NUC.

Related Clinical Trials

NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT06304753 ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction COMPLETED NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT07226583 Using a Personalized Decision Support Tool to Help People With Type 1 Diabetes Manage Exercise NOT_YET_RECRUITING NCT06945952 Efficacy of the Ratio of Respiratory Rate to Diaphragm Thickening Fraction in Prediction of Successful Weaning ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 41488933 A narrative review on the environmental impact of medicines: from water analysis and Frontiers in drug safety and regulation (2025)

Related Devices (Code: NUC)

K161585Mano and Mano Personal LubricantMano and Mano Proprietary Limited K161544Trojan Chain Reaction Personal LubricantChurch & Dwight Co., Inc. K161385Just Like Me Personal LubricantWtfn-Dba Classic Erotica/Holiday Products K152671Pulse Aloe-ahhToaster Labs, Inc. K152628Pulse H20h!Toaster Labs, Inc. K153372Repagyn vaginal suppositoriesFarma-Derma S.R.L.

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.

↑