Cleared Traditional

K003299 - OPD-SCAN, MODELS ARK-10000 AND ARK-9000

K003299 is an FDA 510(k) clearance for OPD-SCAN, manufactured by Nidek Co., Ltd.. The device is a Class 1 Ophthalmic device with product code HLQ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K003299 · Nidek Co., Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K003299

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 110d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

HLQ Device Classification - Class 1, General Controls

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.

Regulatory Peers - HLQ Keratoscope, Ac-powered

All 10
Devices cleared under the same product code (HLQ) and FDA review panel - the closest regulatory comparables to K003299.
EYE SYS VISTA
K973756 · Eyesys Technologies, Inc. · Nov 1997
EYECHEK
K964290 · Reichert Ophthalmic Instruments, Div. Leica, Inc. · Jan 1997
TBD KERATOSCOPE
K912130 · Alcon Laboratories · Aug 1991
CANON AUTO REF-KERATOMETER RK-2
K895475 · Canon USA, Inc. · Oct 1989
CANON SURGICAL AUTO KERATOMETER SK-1
K871936 · Canon USA, Inc. · Jun 1987
NIDEK KM-1000 SURGICAL KERATOMETER
K862137 · Nidek, Inc. · Jul 1986