510(k) Report

Devices descending from K132186

9 later devices reach Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201325Optomed Smartscope M5 with Optomed Smartscope FAOptomed Oyj20200—
+1K180378Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior ModuleOptomed OY20184—
+1K163021Haag-Streit Fundus Module 300Optomed OY20170—
+1K152869LipiView II Ocular Surface InterferometerTearscience, Inc.20161—
+2K251353Eyer 2Phelcom Technologies20260—
+2K252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private Limited20250—
+2K243664Sentinel CameraAi Optics20240—
+2K221329Eyer Retinal Camera NM-STDPhelcom Technologies20232—
+2K182506LipiScan Dynamic Meibomian ImagerTearscience, Inc.20180—