# K132186: Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2

- Pathway: 510(k) (Traditional)
- Applicant: Optomed OY
- Decided: Dec 18, 2013 after 156 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003376 (2001). 4 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110986: Optomed Smartscope M5 EY3 and M5 ES1, Optomed OY (2011) Summary page 1.

## Most influential descendants
- K180378: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module (2018), 4 descendants of its own
- K221329: Eyer Retinal Camera NM-STD (2023), 2 descendants of its own
- K152869: LipiView II Ocular Surface Interferometer (2016), 1 descendant of its own
- K251353: Eyer 2 (2026), 0 descendants of its own
- K252120: Fundus On Phone Non Mydriatic (FOP NM-10) (2025), 0 descendants of its own

## Indications for use
Optomed Smartscope M5 digital camera with EY4 optics module is Intended to capture digital images and video of the fundlus of the human eye. Optomed Smartscope MVS with optics module ESZ IsIntended to capture images and video of the surface of the human eye and surrounding areas.

Source page: https://510kreport.com/device/K132186
Methodology: https://510kreport.com/methodology