510(k) K130549

INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR by Carl Zeiss Meditec, Inc. — Product Code JAD

K130549 is an FDA 510(k) premarket notification submitted by Carl Zeiss Meditec, Inc. for the device "INTRABEAM FLAT APPLICATOR, INTRABEAM SURFACE APPLICATOR". The FDA issued a decision of Substantially Equivalent on June 26, 2013. The device falls under product code JAD (System, Therapeutic, X-Ray), a Class II device regulated under 21 CFR 892.5900. Carl Zeiss Meditec, Inc. has at least 10 other 510(k) clearances on record.