510(k) Report

Devices descending from K123316

2 later devices reach Heine Omega 500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142837Heine Sigma 250 & Heine Sigma 250 M2Heine Optotechnik GmbH & Co. KG20150—
+1K141638Propper Insight Binocular Indirect OphthalmosopePropper Manufacturing Co., Inc.20140—