K-Y Marilyn Pleasure Gel

K-Y Marilyn Pleasure Gel is an FDA 510(k)-cleared medical device (K151884) manufactured by Reckitt Benckiser, LLC. 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 January 10, 2016. Regulation: 8.