# K110986: Optomed Smartscope M5 EY3 and M5 ES1

- Pathway: 510(k) (Traditional)
- Applicant: Optomed OY
- Decided: May 16, 2011 after 38 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: 2 generations back to K003376 (2001). 3 ancestors in all.
20 later devices descend from it; 4 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092056: Optomed Smartscope, Model M3-1 EY1, Optomed OY (2009) Summary page 1.
- K003376: Welch Allyn 11800 Opthalmoscope, Welch Allyn, Inc. (2001) Summary page 1.
- K080681: Kowa Genesis-D, Kowa Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K132186: Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2 (2013), 9 descendants of its own
- K120982: Digital Eye-Fundus Camera (2012), 6 descendants of its own
- 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
- K180306: Nexy (2018), 2 descendants of its own

## Indications for use
Optomed Smartscope M5 camera With optics modules EY3 and ESi is a digital ophthalmoscope intended to capture digital images and video of the fundlus of the human eye and surrounding area.

Source page: https://510kreport.com/device/K110986
Methodology: https://510kreport.com/methodology