
Leica Microsystems, Inc. O.I.D.
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PORTABLE NON-CONTACT TONOMETER, MODEL PT100 is an FDA 510(k)-cleared medical device (K013259) manufactured by Leica Microsystems, Inc. O.I.D.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 19, 2002. Regulation: 8.