Cleared Traditional

K143211 - myVision Track Model 005
(FDA 510(k) Clearance)

K143211 · Vital Art and Science Incorporated · Ophthalmic device

Mar 2015

Decision

130d

Days

Class 1

Risk

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

Submitted by Vital Art and Science Incorporated (Richardson, US). The FDA issued a Cleared decision on March 20, 2015, 130 days after receiving the submission on November 10, 2014.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1330.

Submission Details

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