TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS

TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS is an FDA 510(k)-cleared medical device (K955366) manufactured by Rand Scientific Corp.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 27, 1996. Regulation: 8.