
Bkg Opthalmics USA, Inc.
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ASMOTOM AUTOMATED TREPHINE SYSTEM is an FDA 510(k)-cleared medical device (K013151) manufactured by Bkg Opthalmics USA, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 13, 2001. Regulation: 8.