510(k) Report

Devices descending from K082891

14 later devices reach Lenstar, Model LS900 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey Corporation20250—
+1K150754ARGOSSantec Corporation20151—
+1K143275IOLMaster700Carl Zeiss Meditec, Inc.20154—
+1K133132Optical Biometer AL-ScanNidek Co., Ltd.201401
+1K101182Iolmaster 500Carl Zeiss Meditec, AG2010104
+2K191051ARGOSSantec Corporation20190—
+2K170171IOLMaster 700Carl Zeiss Meditec, AG201731
+2K122418Iolmaster 500Carl Zeiss Meditec, AG201394
+3K173771IOLMaster 700Carl Zeiss Meditec, AG201811
+3K152311Pentacam AXLOculus Optikgerate GmbH201633
+4K252633Unity DX (Udx)Cylite Pty., Ltd.20250—
+4K202989Myopia MasterOculus Optikgeräte GmbH202101
+4K201724Pentacam AXL WaveOculus Optikgerate GmbH202002
+4K182659Galilei G6 Lens ProfessionalSis Ag, Surgical Instrument Systems20190—