510(k) K031831

TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM by Topcon Medical Systems, Inc. — Product Code HKO

K031831 is an FDA 510(k) premarket notification submitted by Topcon Medical Systems, Inc. for the device "TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM". The FDA issued a decision of Substantially Equivalent on December 19, 2003. The device falls under product code HKO (Refractometer, Ophthalmic), a Class I device regulated under 21 CFR 886.1760. Topcon Medical Systems, Inc. has at least 10 other 510(k) clearances on record.