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MEDA Co., Ltd.
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ULTRASONIC BIOMETER FOR OPHTHALMOLOGY ULTRASONIC PACHYMETER is an FDA 510(k)-cleared medical device (K121243) manufactured by MEDA Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 2, 2013. Regulation: 8.