510(k) K102027

AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM by Quantel Medical S.A. — Product Code IYO

K102027 is an FDA 510(k) premarket notification submitted by Quantel Medical S.A. for the device "AXIS NANO OPTHALMIC BIOMETER ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on December 22, 2010. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Quantel Medical S.A. has at least 10 other 510(k) clearances on record.