Cleared Traditional

K050336 - OPD-STATION SOFTWARE (FDA 510(k) Clearance)

Class I Ophthalmic device.

K050336 · Nidek, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
195d
Days
Class 1
Risk

K050336 is an FDA 510(k) clearance for the OPD-STATION SOFTWARE. Classified as Aberrometer, Ophthalmic (product code NCF), Class I - General Controls.

Submitted by Nidek, Inc. (Lake Forest, US). The FDA issued a Cleared decision on August 24, 2005 after a review of 195 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.

View all Nidek, Inc. devices

Submission Details

510(k) Number K050336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2005
Decision Date August 24, 2005
Days to Decision 195 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
85d slower than avg
Panel avg: 110d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NCF Aberrometer, 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.