510(k) K782118

FUL-VUE by American Optical Corp. — Product Code HKN

K782118 is an FDA 510(k) premarket notification submitted by American Optical Corp. for the device "FUL-VUE". The FDA issued a decision of Substantially Equivalent on January 26, 1979. The device falls under product code HKN (Refractor, Manual, Non-Powered, Including Phoropter), a Class I device regulated under 21 CFR 886.1770. American Optical Corp. has at least 10 other 510(k) clearances on record.