Cleared Traditional

K121738 - MYVISIONTRACK(TM) (FDA 510(k) Clearance)

Class I Ophthalmic device.

K121738 · Vital Art and Science Incorporated · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 110d · This submission: 254d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.