Cleared Traditional

K013694 - NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)

K013694 is an FDA 510(k) clearance for NIDEK ADVANCED VISION INFORMATION SYSTE..., manufactured by Nidek, Inc.. The device is a Class 2 Ophthalmic device with product code NFJ cleared through the Traditional 510(k) pathway after a 377-day FDA review.

K013694 · Nidek, Inc. · Ophthalmic device
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Nov 2002
Decision
377d
Days
Class 2
Risk

K013694 is an FDA 510(k) clearance for the NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS). Classified as System, Image Management, Ophthalmic (product code NFJ), Class II - Special Controls.

Submitted by Nidek, Inc. (Lake Forest, US). The FDA issued a Cleared decision on November 19, 2002 after a review of 377 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2050 - 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. Elevated predicate reliance profile. 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 - K013694

510(k) Number K013694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date November 19, 2002
Days to Decision 377 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
267d slower than avg
Panel avg: 110d · This submission: 377d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFJ Device Classification - Class 2, Special Controls

Product Code NFJ System, Image Management, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - NFJ System, Image Management, Ophthalmic

All 50
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