510(k) K220735

Avologi Gel Primer (Model: Av25) by Premier North America, Inc. — Product Code GYB

K220735 is an FDA 510(k) premarket notification submitted by Premier North America, Inc. for the device "Avologi Gel Primer (Model: Av25)". The FDA issued a decision of Substantially Equivalent on September 15, 2023. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Premier North America, Inc. has at least 5 other 510(k) clearances on record.