FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC

FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC is an FDA 510(k)-cleared medical device (K030593) manufactured by X-Cel Contacts, A Walman Co.. 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 29, 2003. Regulation: 8.