Cleared Traditional

OPD-SCAN, MODELS ARK-10000 AND ARK-9000

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

About This 510(k) Submission

K003299 is an FDA 510(k) clearance for the OPD-SCAN, MODELS ARK-10000 AND ARK-9000, a Keratoscope, Ac-powered (Class I — General Controls, product code HLQ), submitted by Nidek Co., Ltd. (Lake Forest, US). The FDA issued a Cleared decision on March 9, 2001, 140 days after receiving the submission on October 20, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1350.

Submission Details

510(k) Number K003299 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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