# K201325: Optomed Smartscope M5 with Optomed Smartscope FA

- Pathway: 510(k) (Traditional)
- Applicant: Optomed Oyj
- Decided: Nov 20, 2020 after 186 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: 4 generations back to K003376 (2001). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132186: Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2, Optomed OY (2013) Summary page 4.
- K091098: Kowagenesis-DF, Kowa Co., Ltd. (2009) Summary page 4.

## Indications for use
Optomed Smartscope M5 digital camera with Smartscope FA optics module is intended to capture fluorescein angiograms of the human eye.

Source page: https://510kreport.com/device/K201325
Methodology: https://510kreport.com/methodology