Julva Velvé Water-Based Personal Lubricant

Julva Velvé Water-Based Personal Lubricant is an FDA 510(k)-cleared medical device (K254101) manufactured by Golden Isles Medical, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 15, 2026. Regulation: 8.