Cleared Traditional

TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM

K031831 · Topcon Medical Systems, Inc. · Ophthalmic

Dec 2003

Decision

189d

Days

Class 1

Risk

About This 510(k) Submission

K031831 is an FDA 510(k) clearance for the TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM, a Refractometer, Ophthalmic (Class I — General Controls, product code HKO), submitted by Topcon Medical Systems, Inc. (Paramus, US). The FDA issued a Cleared decision on December 19, 2003, 189 days after receiving the submission on June 13, 2003. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1760.

Submission Details

510(k) Number	K031831 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 13, 2003
Decision Date	December 19, 2003
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF