
Bausch & Lomb, Inc.
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BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES is an FDA 510(k)-cleared medical device (K071043) manufactured by Bausch & Lomb, 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 August 1, 2007. Regulation: 8.