510(k) K213164

Avaira Vitality by CooperVision, Inc. — Product Code LPL

K213164 is an FDA 510(k) premarket notification submitted by CooperVision, Inc. for the device "Avaira Vitality". The FDA issued a decision of Substantially Equivalent on October 26, 2021. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. CooperVision, Inc. has at least 10 other 510(k) clearances on record.