510(k) K143211

myVision Track Model 005 by Vital Art and Science Incorporated — Product Code HOQ

K143211 is an FDA 510(k) premarket notification submitted by Vital Art and Science Incorporated for the device "myVision Track Model 005". The FDA issued a decision of Substantially Equivalent on March 20, 2015. The device falls under product code HOQ (Grid, Amsler), a Class I device regulated under 21 CFR 886.1330. Vital Art and Science Incorporated has at least 1 other 510(k) clearance on record.