Cleared Traditional

K031831 - TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (FDA 510(k) Clearance)

Class I Ophthalmic device.

K031831 · Topcon Medical Systems, Inc. · Ophthalmic device
Dec 2003
Decision
189d
Days
Class 1
Risk

K031831 is an FDA 510(k) clearance for the TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM. Classified as Refractometer, Ophthalmic (product code HKO), Class I - General Controls.

Submitted by Topcon Medical Systems, Inc. (Paramus, US). The FDA issued a Cleared decision on December 19, 2003 after a review of 189 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1760 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K031831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 156d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HKO Refractometer, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1760
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.