
Topcon Medical Systems, Inc.
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TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM is an FDA 510(k)-cleared medical device (K031831) manufactured by Topcon Medical Systems, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 18, 2003. Regulation: 8.