Sage 2-in-1 Personal Lubricant and Moisturizer

Sage 2-in-1 Personal Lubricant and Moisturizer is an FDA 510(k)-cleared medical device (K190150) manufactured by Fairhaven Health, 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 July 15, 2019. Regulation: 8.