Cleared Traditional

EYEPORT VISION TRAINING SYSTEM (K051684) - FDA 510(k) Clearance

Class I Ophthalmic device.

K051684 · Exercise Your Eyes, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
267d
Days
Class 1
Risk

K051684 is an FDA 510(k) clearance for the EYEPORT VISION TRAINING SYSTEM. Classified as Fixation, Vision Training, Binocular (product code NXR), Class I - General Controls.

Submitted by Exercise Your Eyes, Inc. (Kula, US). The FDA issued a Cleared decision on March 17, 2006 after a review of 267 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1290 - 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 Exercise Your Eyes, Inc. devices

Submission Details

510(k) Number K051684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2005
Decision Date March 17, 2006
Days to Decision 267 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
157d slower than avg
Panel avg: 110d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NXR Fixation, Vision Training, Binocular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1290
Definition To Improve Speed, Accuracy, And Coordination Of Binocular Eye Movements And Changes Of Accommodation. To Treat Poor Accommodation And Vergence Facility, Convergence Insufficiency, And Accommodative Lag.
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.