Cleared Traditional

K121738 - MYVISIONTRACK(TM)

K121738 is an FDA 510(k) clearance for MYVISIONTRACK(TM), 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 254-day FDA review.

K121738 · Vital Art and Science Incorporated · Ophthalmic device
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Feb 2013
Decision
254d
Days
Class 1
Risk

K121738 is an FDA 510(k) clearance for the MYVISIONTRACK(TM). 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 February 22, 2013 after a review of 254 days - an extended review cycle.

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 - K121738

510(k) Number K121738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2012
Decision Date February 22, 2013
Days to Decision 254 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
144d slower than avg
Panel avg: 110d · This submission: 254d
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.