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Optics Laboratory, Inc.
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EYE-CEPT REWETTING DROPS is an FDA 510(k)-cleared medical device (K041008) manufactured by Optics Laboratory, 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 30, 2005. Regulation: 8.