510(k) K092056

OPTOMED SMARTSCOPE, MODEL M3-1 EY1 by Optomed OY — Product Code HKI

K092056 is an FDA 510(k) premarket notification submitted by Optomed OY for the device "OPTOMED SMARTSCOPE, MODEL M3-1 EY1". The FDA issued a decision of Substantially Equivalent on October 1, 2009. The device falls under product code HKI (Camera, Ophthalmic, Ac-Powered), a Class II device regulated under 21 CFR 886.1120. Optomed OY has at least 7 other 510(k) clearances on record.