510(k) Report

Devices descending from K110986

20 later devices reach Optomed Smartscope M5 EY3 and M5 ES1 through their predicates, nearest generation first.

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