Cleared Traditional

K050336 - OPD-STATION SOFTWARE

K050336 is an FDA 510(k) clearance for OPD-STATION SOFTWARE, manufactured by Nidek, Inc.. The device is a Class 1 Ophthalmic device with product code NCF cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K050336 · Nidek, Inc. · Ophthalmic device
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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

FDA 510(k) Submission Details - K050336

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 110d · This submission: 195d
Pathway characteristics
Predicate-based equivalence.

NCF Device Classification - Class 1, General Controls

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.