Cleared Traditional

K143211 - myVision Track Model 005

K143211 is an FDA 510(k) clearance for myVision Track Model 005, manufactured by Vital Art and Science Incorporated. The device is a Class 1 Ophthalmic device with product code HOQ cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K143211 · Vital Art and Science Incorporated · Ophthalmic device
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Mar 2015
Decision
130d
Days
Class 1
Risk

K143211 is an FDA 510(k) clearance for the myVision Track Model 005. Classified as Grid, Amsler (product code HOQ), Class I - General Controls.

Submitted by Vital Art and Science Incorporated (Richardson, US). The FDA issued a Cleared decision on March 20, 2015 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1330 - 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 Vital Art and Science Incorporated devices

FDA 510(k) Submission Details - K143211

510(k) Number K143211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2014
Decision Date March 20, 2015
Days to Decision 130 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
20d slower than avg
Panel avg: 110d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

HOQ Device Classification - Class 1, General Controls

Product Code HOQ Grid, Amsler
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1330
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 Consultant

O'Connell Regulatory Consultants, Inc.
Maureen O'Connell

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.