# K092056: Optomed Smartscope, Model M3-1 EY1

- Pathway: 510(k) (Traditional)
- Applicant: Optomed OY
- Decided: Oct 1, 2009 after 86 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: 1 generation back to K003376 (2001). 2 ancestors in all.
22 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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
- K110986: Optomed Smartscope M5 EY3 and M5 ES1 (2011), 20 descendants of its own
- 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

## Indications for use
Optomed Smartscope M3-1 EY1 digital ophthalmoscope is intended to capture digital images and video of the cornea, aqueous, lens, vitreous and retina of the human eye.

Source page: https://510kreport.com/device/K092056
Methodology: https://510kreport.com/methodology