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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K254101

510(k) cleared

Julva Velvé Water-Based Personal Lubricant

Golden Isles Medical, Inc. · Apr 16, 2026 · K254101

FDA cleared the Julva Velvé Water-Based Personal Lubricant from Golden Isles Medical, Inc. on Apr 16, 2026 under K254101, a traditional 510(k). The device falls under product code NUC, Lubricant, Personal, regulated at 21 CFR 884.5300 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Dec 19, 2025. The decision came 118 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Golden Isles Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254101?

K254101 is the FDA 510(k) for Julva Velvé Water-Based Personal Lubricant, submitted by Golden Isles Medical, Inc.. FDA's decision date was Apr 16, 2026, under product code NUC (Lubricant, Personal).

Who makes the Julva Velvé Water-Based Personal Lubricant?

Golden Isles Medical, Inc., based in Brunswick, GA, is the applicant of record for K254101.

How long did the K254101 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on Apr 16, 2026, 118 days later.

← All decisions in April 2026