510(k) Report

Devices descending from K080681

23 later devices reach Kowa Genesis-D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121405PanopticWelch Allyn, Inc.20121—
+1K110986Optomed Smartscope M5 EY3 and M5 ES1Optomed OY201120—
+1K092056Optomed Smartscope, Model M3-1 EY1Optomed OY200922—
+2K223381iExaminer System with Panoptic PlusWelch Allyn, Inc.20230—
+2K161727Eyenez Ophthalmic CameraEyenez, LLC20160—
+2K132186Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2Optomed OY20139—
+2K120982Digital Eye-Fundus CameraMedimaging Integrated Solutions, Inc. (Miis)20126—
+2K111531RHA2020Annidis Health Systems Corp.20110—
+3K201325Optomed Smartscope M5 with Optomed Smartscope FAOptomed Oyj20200—
+3K173474RetiCaptureIlooda Co,., Ltd.20180—
+3K180306NexyNext Sight Srl20182—
+3K180378Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleOptomed OY20184—
+3K170470Digital Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)20171—
+3K163021Haag-Streit Fundus Module 300Optomed OY20170—
+3K152869LipiView II Ocular Surface InterferometerTearscience, Inc.20161—
+4K251353Eyer 2Phelcom Technologies20260—
+4K252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private Limited20250—
+4K250683Resolve Fundus CameraOptain Health, Inc.20250—
+4K243664Sentinel CameraAi Optics20240—
+4K221329Eyer Retinal Camera NM-STDPhelcom Technologies20232—
+4K202221VX650Luneau Technology Operations20210—
+4K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis)20200—
+4K182506LipiScan Dynamic Meibomian ImagerTearscience, Inc.20180—