510(k) Report

Devices descending from K973533

37 later devices reach Nidek Stereo Disc Camera (3-DX)/Nidek Stereo Fundus Camera (3-DXF) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101628Kowa Nonmyd WXKowa Co., Ltd.20112—
+1K991284Anterior Eye-Segment Analysis SystemNidek, Inc.199933—
+2K191945KOWA nonmyd 8Kowa Company, Ltd.20190—
+2K132987Cobra Fundus CameraC.S.O. S.R.L.20140—
+2K030719Pentacam Scheimpflug CameraOculus Optikgerate GmbH2003181
+2K012873Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc.200118—
+3K152311Pentacam AXLOculus Optikgerate GmbH201633
+3K143086VX120 Ophthalmic Diagnostic DeviceLuneau Sas20153—
+3K133132Optical Biometer AL-ScanNidek Co., Ltd.201401
+3K111505Rtvue Cam with Corneal Power UpgradeOptovue, Inc.201181
+3K071183Allegro OculyzerWavelight AG20070—
+3K040913Ngdi (Next Generation Diagnostic Instrument)Bausch & Lomb20040—
+3K030393Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG200316—
+4K202989Myopia MasterOculus Optikgeräte GmbH202101
+4K201724Pentacam AXL WaveOculus Optikgerate GmbH202002
+4K182659Galilei G6 Lens ProfessionalSis Ag, Surgical Instrument Systems20190—
+4K180660AvantiOptovue, Inc.20185—
+4K162067VX130 Ophthalmic Diagnostic DeviceLuneau Sas20171—
+4K121622Nidek RS-3000Nidek Co., Ltd.20131—
+4K082891Lenstar, Model LS900Haag-Streit AG2009143
+4K052935Heidelberg Engineering Slitlamp-Oct (SL-Oct)Heidelberg Engineering20060—
+5K252348Tomey Optical Biometer OA-2000 (OA-2000)Tomey Corporation20250—
+5K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software…Nidek Co., Ltd.20230—
+5K222166SOLIXOptovue, Inc.20221—
+5K213265Tomey Cornea/Anterior Segment OCT CASIA2Tomey Corporation20221—
+5K202221VX650Luneau Technology Operations20210—
+5K150754ARGOSSantec Corporation20151—
+5K143275IOLMaster700Carl Zeiss Meditec, Inc.20154—
+5K132323RS-3000 AdvanceNidek Co., Ltd.20140—
+5K101182Iolmaster 500Carl Zeiss Meditec, AG2010104
+6K251848Pentacam® Cornea OCTOculus Optikgeräte GmbH20260—
+6K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation20250—
+6K191051ARGOSSantec Corporation20190—
+6K170171IOLMaster 700Carl Zeiss Meditec, AG201731
+6K122418Iolmaster 500Carl Zeiss Meditec, AG201394
+7K173771IOLMaster 700Carl Zeiss Meditec, AG201811
+8K252633Unity DX (Udx)Cylite Pty., Ltd.20250—