510(k) Report

Devices descending from K180378

4 later devices reach Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K251353Eyer 2Phelcom Technologies20260—
+1K252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private Limited20250—
+1K243664Sentinel CameraAi Optics20240—
+1K221329Eyer Retinal Camera NM-STDPhelcom Technologies20232—