Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is an FDA 510(k)-cleared medical device (K210975) manufactured by Bausch & Lomb, Incorporated. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2021. Regulation: 8.