Bloomi Smooth Water Based Lubricant

Bloomi Smooth Water Based Lubricant is an FDA 510(k)-cleared medical device (K221328) manufactured by The Bloomi 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 August 3, 2022. Regulation: 8.