
Insight Instruments, Inc.
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SUPER VIEW DISPOSABLE BIOM LENS SET is an FDA 510(k)-cleared medical device (K051630) manufactured by Insight Instruments, 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 June 28, 2005. Regulation: 8.