Cleared Traditional

OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (K003299) - FDA 510(k) Clearance

Class I Ophthalmic device.

K003299 · Nidek Co., Ltd. · Ophthalmic device
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Mar 2001
Decision
140d
Days
Class 1
Risk

K003299 is an FDA 510(k) clearance for the OPD-SCAN, MODELS ARK-10000 AND ARK-9000. Classified as Keratoscope, Ac-powered (product code HLQ), Class I - General Controls.

Submitted by Nidek Co., Ltd. (Lake Forest, US). The FDA issued a Cleared decision on March 9, 2001 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1350 - 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.

View all Nidek Co., Ltd. devices

Submission Details

510(k) Number K003299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received October 20, 2000
Decision Date March 09, 2001
Days to Decision 140 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 110d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HLQ Keratoscope, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1350
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.