510(k) K180820

Tono Vue Non-Contact Tonometer by Crystalvue Medical Corporation — Product Code HKX

K180820 is an FDA 510(k) premarket notification submitted by Crystalvue Medical Corporation for the device "Tono Vue Non-Contact Tonometer". The FDA issued a decision of Substantially Equivalent on December 14, 2018. The device falls under product code HKX (Tonometer, Ac-Powered), a Class II device regulated under 21 CFR 886.1930. Crystalvue Medical Corporation has at least 2 other 510(k) clearances on record.