510(k) K163659

Crystal Vision by I.C Medical, Inc. — Product Code FYD

K163659 is an FDA 510(k) premarket notification submitted by I.C Medical, Inc. for the device "Crystal Vision". The FDA issued a decision of Substantially Equivalent on October 30, 2017. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. I.C Medical, Inc. has at least 10 other 510(k) clearances on record.