LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is an FDA 510(k)-cleared medical device (K202241) manufactured by Hamilton Thorne, 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 July 1, 2021. Regulation: 8.