510(k) K180322

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens by Visco Vision, Inc. — Product Code LPL

K180322 is an FDA 510(k) premarket notification submitted by Visco Vision, Inc. for the device "Si-Hy (olifilcon B) color silicone hydrogel soft contact lens". The FDA issued a decision of Substantially Equivalent on Apr 20, 2018. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Visco Vision, Inc. has 10 other 510(k) clearances on record.