510(k) K122973

AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE by Medgyn Products, Inc. — Product Code HEX

K122973 is an FDA 510(k) premarket notification submitted by Medgyn Products, Inc. for the device "AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE". The FDA issued a decision of Substantially Equivalent on June 12, 2013. The device falls under product code HEX (Colposcope (And Colpomicroscope)), a Class II device regulated under 21 CFR 884.1630. Medgyn Products, Inc. has at least 4 other 510(k) clearances on record.