ELITA™ Femtosecond Laser System, ELITA™ Patient Interface

ELITA™ Femtosecond Laser System, ELITA™ Patient Interface is an FDA 510(k)-cleared medical device (K223566) manufactured by Johnson & Johnson Surgical Vision, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 13, 2023. Regulation: 8.