Fundus On Phone Non Mydriatic (FOP NM-10)

The FOP NM-10 is a portable, non-mydriatic ophthalmic digital camera that attaches to an iPhone SE3 to capture high-resolution images of the fundus (retina) and surrounding eye structures without requiring pupil dilation. It uses infrared and white LED illumination for retinal imaging and is intended for use in hospitals, clinics, and optical shops by trained eye care professionals.

The device offers a 40° field of view, manual and tap-to-focus capability, diopter correction from -16D to +16D, 8 internal fixation points, and operates across temperatures of 10–40°C. It captures color, infrared, and red-free images with 64 line pairs per millimeter resolution, uses Bluetooth-controlled illumination intensity, and stores images internally via Wi-Fi over HTTPS. Key differences from predicates include use of iPhone SE3 (vs. Samsung Galaxy S10 or dedicated hardware) and a narrower diopter range (-16D to +16D vs. -20D to +20D).

IEC 60601-1:2005+A1:2012 (electrical safety), IEC 60601-1-2:2014 (EMC), ISO 15004-1:2020, ISO 15004-2:2024 (ophthalmic instruments), ANSI Z80.36:2021 (optical performance), ISO 10940:2009 (fundus cameras), IEC 62304:2015 (software verification), ISO 10993-5:2009 and ISO 10993-10:2010 (biocompatibility), and IEC 62366-1:2015 (usability/human factors).

FOP NM-10 is substantially equivalent to predicate devices (Eyer Retinal Camera NM-STD and Optomed Aurora Camera) because it shares the same intended use (non-mydriatic fundus imaging), same regulatory class (Class II), same product code (HKI), and comparable technology (infrared and white LED illumination, internal fixation targets, manual focus, similar optical and performance specifications). No new safety or effectiveness issues are introduced; design and testing confirm compliance with applicable standards and performance comparable to predicates.