# K080681: Kowa Genesis-D

- Pathway: 510(k) (Special)
- Applicant: Kowa Co., Ltd.
- Decided: Apr 4, 2008 after 25 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
No predicates in its family tree.
23 later devices descend from it; 3 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)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K053027: VSM Vital Signs Monitor, Model 53000 (VSM 300), Welch Allyn, Inc. (2005). Our reading of the summary gave K053027, FDA’s number for VSM Vital Signs Monitor, Model 53000 (VSM 300) (Welch Allyn, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “KOWA GENESIS”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K092056: Optomed Smartscope, Model M3-1 EY1 (2009), 22 descendants of its own
- 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

## Indications for use
The KOWA hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.

Source page: https://510kreport.com/device/K080681
Methodology: https://510kreport.com/methodology